Other Medical Devices

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics

Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached.

Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.

Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.

Potential for attenuation degradation over time, decreasing the lifespan.

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Potential for attenuation degradation over time, decreasing the lifespan.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.

In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.