Medical equipment, implants, and diagnostic devices
Tosoh Bioscience
The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. The firm received complaints that the A2 peak could not be detected with the G7 Beta-thalessemia columns.
Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.
Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.
Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.
Lighthouse For The Blind
The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili
Toshiba American Medical Systems
The firm initiated this recall due to a potential software issue. The DLP (Dose Length Product) value may be displayed incorrectly when the vHP option is used.
Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure.
Lighthouse For The Blind
The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili
The firm was notified by their customers that there was a water leakage from the white tubing connector.
Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.
Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention
Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.
Lighthouse For The Blind
The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili
Siemens Healthcare Diagnostics
Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.
LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.
Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
Siemens Medical Solutions USA
Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. This malfunction is possible in cases where the table vertical lift movement is obstructed by a solid object which could potentially result in collision. This can re
The Column rotation can accidentally be moved to a different position which in the locked position.
Lighthouse For The Blind
The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili
Siemens Medical Solutions USA
A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc.