All Recalls

Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it. May delay treatment if changing to a different system.

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting.

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Instances of data sets not being accurately registered to the patient anatomy were observed.

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs) while connected to AC power: On the HeartStart MRx and HeartStart XL, EFT noise can be misinterpreted as an R-wave. On the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing.

The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated with the procedure. Use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.

Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected electrodes will transmit a poor signal or no signal at all before reaching the indicated expiration date.

The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal

Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct.