Medical device recalls

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).

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).

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.

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

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.

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

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

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.

Affected products were assembled off-site by individuals who may not have been properly trained.

Affected products were assembled off-site by individuals who may not have been properly trained.

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.

Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory was used with the VST clamp as a monitor mount on the boom.

Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.

Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue.

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.

The product is not able to provide irrigation.

The product is not able to provide irrigation.

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

Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

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