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.
- 2019-05-29FDA-DeviceNeusoft Medical Systems Co., Ltd.Class IINeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.
- 2019-05-29FDA-DeviceEdwards Lifesciences, LLCClass IEV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor).
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
- 2019-05-22FDA-DeviceArrow International IncClass IIArrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.
Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC
- 2019-05-22FDA-DeviceArrow International IncClass IIArrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.
Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC
- 2019-05-22FDA-DeviceAbbott LaboratoriesClass IIITechnopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Devices were delivered without the required dry ice.
- 2019-05-22FDA-DeviceAbbott LaboratoriesClass IIITechnopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Devices were delivered without the required dry ice.
- 2019-05-22FDA-DeviceAbbott LaboratoriesClass IIIALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.
Devices were delivered without the required dry ice.
- 2019-05-22FDA-DeviceAbbott LaboratoriesClass IIIARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.
Devices were delivered without the required dry ice.
- 2019-05-22FDA-DeviceAbbott LaboratoriesClass IIIARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.
Devices were delivered without the required dry ice.
- 2019-05-22FDA-DeviceAbbott LaboratoriesClass IIIARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
Devices were delivered without the required dry ice.
- 2019-05-22FDA-DeviceAbbott LaboratoriesClass IIIARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
Devices were delivered without the required dry ice.
- 2019-05-22FDA-DeviceAbbott LaboratoriesClass IIIARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.
Devices were delivered without the required dry ice.
- 2019-05-22FDA-DeviceAbbott LaboratoriesClass IIIARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.
Devices were delivered without the required dry ice.
- 2019-05-22FDA-DeviceAbbott Ireland Diagnostics DivisionClass IIAbbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
- 2019-05-22FDA-DeviceAbbott Ireland Diagnostics DivisionClass IIAbbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
- 2019-05-22FDA-DeviceMoller VitalClass IIMolift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003
The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall.
- 2019-05-22FDA-DeviceMoller VitalClass IIMolift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021
The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall.
- 2019-05-22FDA-DeviceStryker Medical Division of Stryker CorporationClass IIPower-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
- 2019-05-22FDA-DeviceStanley Security Solutions IncClass IIM200 Fall Monitoring System
Damaged capacitor on the printed circuit board.
- 2019-05-22FDA-DeviceCompass Health Brands (Corporate Office)Class IIMediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
Product design change did not receive proper premarket clearance and lacks a 510 (k)
- 2019-05-22FDA-DeviceCompass Health Brands (Corporate Office)Class IIMediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S
Product design change did not receive proper premarket clearance and lacks a 510 (k)
- 2019-05-22FDA-DeviceCompass Health Brands (Corporate Office)Class IIMediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S
Product design change did not receive proper premarket clearance and lacks a 510 (k)
- 2019-05-22FDA-DeviceCompass Health Brands (Corporate Office)Class IIMediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S
Product design change did not receive proper premarket clearance and lacks a 510 (k)
- 2019-05-22FDA-DeviceCompass Health Brands (Corporate Office)Class IIMediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S
Product design change did not receive proper premarket clearance and lacks a 510 (k)
- 2019-05-22FDA-DeviceCompass Health Brands (Corporate Office)Class IIMediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
Product design change did not receive proper premarket clearance and lacks a 510 (k)
- 2019-05-22FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiog
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
- 2019-05-22FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiog
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
- 2019-05-22FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
- 2019-05-22FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose an
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
- 2019-05-22FDA-DeviceIntegra LimitedClass IIIntegra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.
Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
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