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.

2019-03-06FDA-DevicePhilips Medical Systems NederlandsClass II
Intera 0.5T Standard, Model Number 781101. Nuclear Magnetic Resonance Imaging System
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
2019-03-06FDA-DevicePhilips Medical Systems NederlandsClass II
Multiva 1.5T 16 R5, Model Number 781078. Nuclear Magnetic Resonance Imaging System
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
2019-03-06FDA-DevicePhilips Medical Systems NederlandsClass II
Multiva 1.5T 16 R5 (ZBO), Model Number 781073. Nuclear Magnetic Resonance Imaging System
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
2019-03-06FDA-DevicePhilips Medical Systems NederlandsClass II
Multiva 1.5T 8 R5 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Imaging System
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
2019-03-06FDA-DevicePhilips Medical Systems NederlandsClass II
Prodiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging System
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
2019-03-06FDA-DevicePhilips Medical Systems NederlandsClass II
Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
2019-03-06FDA-DeviceZimmer Biomet Spine Inc.Class II
Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications
The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications
2019-03-06FDA-DeviceZimmer Biomet Spine Inc.Class II
Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications.
The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications
2019-03-06FDA-DeviceZimmer Biomet Spine Inc.Class II
Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications
The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications
2019-03-06FDA-DevicePhysio-Control IncClass I
LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 monitor/defibrillator
Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.
2019-03-06FDA-DevicePhysio-Control IncClass I
LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 monitor/defibrillator is designed t
Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.
2019-03-06FDA-DeviceICU Medical, Inc.Class I
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.
There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
2019-02-27FDA-DeviceShimadzu Medical Systems Usa ComClass II
TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure. Event 2: In rare cases a synchronization error may occur in the data transmission circuit in the device due to external noise. The visibility of the displayed image may be corrupted (images become bit-shifted abnormal images). If this event occurs, it may become difficult to see the object, which may hinder the examination and treatment.
2019-02-27FDA-DevicePhilips North America, LLCClass II
PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
2019-02-27FDA-DevicePhilips North America, LLCClass II
PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
2019-02-27FDA-DevicePhilips North America, LLCClass II
PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
2019-02-27FDA-DevicePhilips North America, LLCClass II
PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
2019-02-27FDA-DevicePhilips North America, LLCClass II
PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evaluate the electrocardiogram of adult and pediatric patients
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
2019-02-27FDA-DevicePhilips North America, LLCClass II
PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
2019-02-27FDA-DevicePhilips North America, LLCClass II
PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
2019-02-27FDA-DevicePhilips North America, LLCClass II
PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
2019-02-27FDA-DevicePhilips North America, LLCClass II
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
2019-02-27FDA-DeviceBoston Scientific CorporationClass II
Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
2019-02-27FDA-DeviceCook Inc.Class II
Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
The products were manufactured with longer than specified sheaths.
2019-02-27FDA-DeviceBaxter Healthcare CorporationClass II
Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
2019-02-27FDA-DeviceBaxter Healthcare CorporationClass II
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
2019-02-27FDA-DeviceOrtho-Clinical DiagnosticsClass II
VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.
Negative bias results when using VITROS VALP Reagent, GEN 25.
2019-02-27FDA-DevicebioMerieux, Inc.Class II
VITEK 2 AST-N351 Test Kit
False Positive ESBL Phenotype
2019-02-27FDA-DeviceTeleflex MedicalClass II
Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
The internal tip is missing from the device, causing the device to not function as intended.
2019-02-27FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class II
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer. A failure mode of the power supply has been found where an electrical short occurs on the low voltage direct current connector and results in the connector heating up, generating smoke, melting and in some cases disconnecting from the programmer.

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