Other Medical Devices

The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch.

3M is conducting a voluntary product recall of selected lots of 3M" Scotchcast" Wet or Dry Cast Padding. Upon investigation of a health care provider feedback, and confirmed with internal testing, it was found that the cast padding material does not consistently repel water. Lack of repellency may result in prolonged cast dry times after exposure to wet conditions. There have been no repo

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled.

It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6

Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

A potential lack of certification, and/or missing laser certification, laser safety warning and administrative labels, and potentially incomplete Performance Feature set and incomplete User Information were discovered.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.