Medical Devices Recalls

Expired Products distributed to customers

VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.

Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery

The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000 Access Immunoassay Analyzer may generate a System Event log message that indicates PnP errors. Any cancelled tests will have an associated SYS flag. The analyzer may enter the Red-system status because of this issue. The analyzer also may not eject RVs, where unbound conjugate could potentially splash up on the sidewall of the RV, not being properly washed away, resulting in an artificially higher signal (RLU). The analyzer may not detect this splashing and continue with normal operation, which can cause false low or high erroneous results. Consequently, the analyzer may cancel in-progress tests. These errors could potentially cause delay reporting patient test results and patient treatments. The degree of the potential health hazard is dependent on the analytes that are potentially delayed, especially those analytes that would be used in the acute setting when treatment decisions are immediate. In this particular recall the highest risk analyte is troponin. Health consequences could include permanent impairment or possibly death if medical treatment decisions are delayed due to a delay in obtaining patient results. The issue was identified by Beckman Coulter Inc. manufacturing staff at their location in Brea California on February 29, 2024, during in-process acceptance inspection activities.

HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configuration of the modular Instrument removed the primary light source and the excitation monochromator. A plastic cap was installed to plug the optical port, where a more durable beam stop should have been used. The defect may allow the class 4 laser beam to burn (or transmit) through the plastic cap to exit the protective enclosure.

A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.

Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.

Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.

Potential for inaccurate fetal heart rate measurements when monitoring multiples.

One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.

Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.