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.
- 2019-05-01FDA-DeviceSiemens Medical Solutions USA, IncClass IISiemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software version 13.0.302 and higher; Control Console from software version 9.2.400 and higher; and Control Console from software version 11.0.400 and higher.
Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment disabling the Auto Field Sequence (AFS) Automatic Motion Protection (AMP) function implemented at the control of the Digital Linear Accelerator.
- 2019-05-01FDA-DeviceThoratec Corp.Class IIThoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.
Small black plastic particle was observed in the left ventricle during implant procedure.
- 2019-05-01FDA-DeviceCytocell Ltd.Class IIIAquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
There is an error in the chromomap included in the labeling for the product.
- 2019-05-01FDA-DeviceEdwards Lifesciences, LLCClass IEdwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepted technique for palliation of several congenital cardiac defects. Description of Use Balloon atrioseptostomy can be performed in conjunction with diagnostic cardiac catheterization or under echocardiographic guidance and
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
- 2019-05-01FDA-DeviceEdwards Lifesciences, LLCClass IEdwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepted technique for palliation of several congenital cardiac defects. Description of Use Balloon atrioseptostomy can be performed in conjunction with diagnostic cardiac catheterization or under echocardiographic guidanc
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
- 2019-05-01FDA-DeviceKaVo Dental Technologies LLCClass IIcone-beam CT system
ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
- 2019-04-24FDA-DeviceGE Healthcare, LLCClass IIInnova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.
- 2019-04-24FDA-DeviceGE Healthcare, LLCClass IIInnova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.
- 2019-04-24FDA-DeviceGE Healthcare, LLCClass IIInnova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.
- 2019-04-24FDA-DeviceCordis CorporationClass IIICordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Frayed pieces of the mounting card being inside the primary packaging.
- 2019-04-24FDA-DeviceAbbott Gmbh & Co. KGClass IIAbbott Alinity c Processing Module LN 03R67-01 - Product Usage: 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. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electri
The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System.
- 2019-04-24FDA-DeviceAbbott Gmbh & Co. KGClass IIAbbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System.
- 2019-04-24FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIsyngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and connectivity features.
Software Issues.
- 2019-04-24FDA-DeviceRoche Diagnostics CorporationClass IIAlbumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
- 2019-04-24FDA-DeviceMedrobotics CorporationClass IIObturator (shortcone), Part number 26114 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualiza
The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
- 2019-04-24FDA-DeviceMedrobotics CorporationClass IIObturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualiza
The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
- 2019-04-24FDA-DeviceAniara Diagnostica LLCClass IIIBIOPHEN LMWH Control C4, REF 224201
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
- 2019-04-24FDA-DeviceAniara Diagnostica LLCClass IIIBIOPHEN UFH Control C1, REF 224101
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
- 2019-04-24FDA-DeviceAniara Diagnostica LLCClass IIIBIOPHEN UFH Control C2, REF 223901
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
- 2019-04-24FDA-DeviceGyrus ACMI, Inc.Class IIDiego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- 2019-04-24FDA-DeviceGyrus ACMI, Inc.Class IIDiego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- 2019-04-24FDA-DeviceGyrus ACMI, Inc.Class IIDiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- 2019-04-24FDA-DeviceGyrus ACMI, Inc.Class IIDiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- 2019-04-24FDA-DeviceGyrus ACMI, Inc.Class IIDiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- 2019-04-24FDA-DeviceGyrus ACMI, Inc.Class IIDiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- 2019-04-24FDA-DeviceGyrus ACMI, Inc.Class IIDiego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- 2019-04-24FDA-DeviceGyrus ACMI, Inc.Class IIDiego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- 2019-04-24FDA-DeviceGyrus ACMI, Inc.Class IIDiego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- 2019-04-24FDA-DeviceGyrus ACMI, Inc.Class IIOlympus Diego Elite Console MDCONS 100
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- 2019-04-24FDA-DeviceProSun International, LLCClass IIProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE (TMAX READY), PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE, PROSUN V3 42 HIGH INTENSIVE (160W) RED, PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE TMAX READY
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief