Medical Devices Recalls

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions

Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.

It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.