Other Medical Devices

It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are blocked and can only be reactivated by a field service engineer.

There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).

Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton

The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.

Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is applied to the foot.

There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.

The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.

After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.

Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.

Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton

CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.

Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform automatic processing of the urination sound signal, resulting in lower urination volume and velocity values than expected.

Backup batteries can fail earlier than their estimated life.

The product is not able to provide irrigation.

A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.

An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100 through 3.9.300. Calls placed from a push button call device, such as a push button switch, call cord, or from the push buttons on a room audio station, will be canceled on the nurse call system when the call is answered at the wireless phone, regardless of the call priority.

Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.

Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.

A nonsterile component was packaged in a sterile convenience kit.

One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates