Other Medical Devices

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

Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.

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 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.

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

LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.

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.

Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h

Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h

Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h

An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.

The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor.

The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.

The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.

Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.

The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.

Incorrect size was printed on the outer product packaging.

Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.