Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-06-12FDA-DeviceCenturion Medical Products CorporationClass IISterile Nail Clipper Concave Edge (67710)
Compromised seal on the sterile barrier pouch.
- 2019-06-12FDA-DeviceI.T.S. GmbHClass IIRim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
The titanium implant has the wrong article number laser marked on it.
- 2019-06-12FDA-DeviceOMNIlife science Inc.Class IIOMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot robotic Motor Unit, and for preparation of the bone for implant implantation. The instrument has been designed to facilitate bone preparation and implantation of the OMNI Apex Knee System.
The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
- 2019-06-12FDA-DeviceFlowonix Medical IncClass IIPrometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
- 2019-06-12FDA-DeviceFlowonix Medical IncClass IIPrometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
- 2019-06-12FDA-DeviceFlowonix Medical IncClass IIPrometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
- 2019-06-12FDA-DeviceFlowonix Medical IncClass IIPrometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.
- 2019-06-12FDA-DeviceFlowonix Medical IncClass IIPrometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.
- 2019-06-12FDA-DeviceBecton Dickinson & CompanyClass IIBD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.
- 2019-06-12FDA-DeviceAbbott Gmbh & Co. KGClass IIAlinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology.
Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample probe being unable to make efficient contact with the cuvette bottom.
- 2019-06-12FDA-DeviceStryker NeurovascularClass IIStryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-90, 90cm Product Usage: Indications for Use: The AXS Infinity LS Plus Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. Device Description: The AXS Infinity LS Plus Long Sheath is a single lumen, flexible, variable st
A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.
- 2019-06-12FDA-DeviceNxStage Medical, Inc.Class IINxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Certain lots were mislabeled with incorrect product number.
- 2019-06-12FDA-DeviceNxStage Medical, Inc.Class IINxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Certain lots were mislabeled with incorrect product number.
- 2019-06-12FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIAngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
- 2019-06-12FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIAngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
- 2019-06-12FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIAngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
- 2019-06-12FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIAngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
- 2019-06-12FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIAngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
- 2019-06-12FDA-DeviceFresenius Medical Care Renal Therapies Group, LLCClass III2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
- 2019-06-12FDA-DeviceMicroline Surgical, Inc.Class IITLS2 Thermal Ligating Shears, Catalog Number 132-131D
The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.
- 2019-06-12FDA-DeviceAccuray IncorporatedClass IICyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System
There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.
- 2019-06-12FDA-DeviceAccuray IncorporatedClass IICyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS
There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.
- 2019-06-12FDA-DevicePhilips North America, LLCClass IIIntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when con
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
- 2019-06-12FDA-DevicePhilips North America, LLCClass IIIntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not auto
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
- 2019-06-12FDA-DevicePhilips North America, LLCClass IIIntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467821, 453564467841, 453564467861, 453564262531, and 453564262551 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue In
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
- 2019-06-12FDA-DevicePhilips North America, LLCClass IIIntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
- 2019-06-12FDA-DeviceOriGen Biomedical, Inc.Class IECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
- 2019-06-12FDA-DeviceOriGen Biomedical, Inc.Class IECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
- 2019-06-12FDA-DeviceOriGen Biomedical, Inc.Class IECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
- 2019-06-12FDA-DeviceOriGen Biomedical, Inc.Class IECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
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