Medical device recalls
39137 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-07-14FDA-DeviceCardinal Health 200, LLCClass IINonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
- 2021-07-14FDA-DeviceCardinal Health 200, LLCClass IISterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
- 2021-07-14FDA-DeviceCardinal Health 200, LLCClass IINonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
- 2021-07-14FDA-DeviceCardinal Health 200, LLCClass IISterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
- 2021-07-14FDA-DeviceThe Binding Site Group, Ltd.Class IIFREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
- 2021-07-14FDA-DeviceSiemens Medical Solutions USA, IncClass IIARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system
- 2021-07-14FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.
- 2021-07-14FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.
- 2021-07-14FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.
- 2021-07-14FDA-DeviceVivorte, Inc.Class IIVivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018
- 2021-07-14FDA-DeviceGE Healthcare, LLCClass IIThe system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either withor without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a var
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.
- 2021-07-14FDA-DeviceGE Healthcare, LLCClass IIThe system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained e
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.
- 2021-07-14FDA-DeviceGE Healthcare, LLCClass IIThe system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.
- 2021-07-14FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIThe ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in vitro diagnostic use.
ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection setting of 2; an erroneously elevated or depressed patient result to be reported without alert on the test result
- 2021-07-14FDA-DeviceRandox Laboratories Ltd.Class IIRandox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
- 2021-07-14FDA-DeviceSentinel CH SpAClass IIIACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New IFU instructions for handling the product provided to end users.
- 2021-07-14FDA-DeviceLuminex CorporationClass IIVerigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
Potential for a false-negative result.
- 2021-07-14FDA-DeviceLuminex CorporationClass IIVerigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
Potential for a false-negative result.
- 2021-07-14FDA-DeviceLuminex CorporationClass IIVerigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Potential for a false-negative result.
- 2021-07-14FDA-DeviceLuminex CorporationClass IIVerigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Potential for a false-negative result.
- 2021-07-14FDA-DeviceLuminex CorporationClass IIVerigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
Potential for a false-negative result.
- 2021-07-14FDA-DeviceLuminex CorporationClass IIVerigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Potential for a false-negative result.
- 2021-07-14FDA-DeviceGE Healthcare, LLCClass IIRevolution CT
GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
- 2021-07-14FDA-DeviceBoston Scientific CorporationClass IIVISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
- 2021-07-14FDA-DeviceBoston Scientific CorporationClass IIVALITUDE CRT-P pacemaker, Models: a) U125 b) U128
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
- 2021-07-14FDA-DeviceBoston Scientific CorporationClass IIAltrua 2 pacemaker, Models: a) S701 b) S702 c) S722
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
- 2021-07-14FDA-DeviceBoston Scientific CorporationClass IIAccolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
- 2021-07-14FDA-DeviceBoston Scientific CorporationClass IIProponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
- 2021-07-14FDA-DeviceBoston Scientific CorporationClass IIEssentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
- 2021-07-14FDA-DeviceLIEBEL-FLARSHEIM COMPANY LLCClass IIHydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ¿ 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.
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