Medical Devices Recalls

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

GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting during procedure. The boot issue may occur when a large amount of patient data remains in the browser and is not deleted. The inability to boot the system ma

GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR, SpO2 or Invasive pressure alarm limits from the iCentral over the network, the alarm priority on th

During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.

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

Potential carryover issue that can can cause shortened APTT clotting times on the instrument.

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

Microbore tubing disconnecting from male luers on the extension sets.

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.

During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back into the manual during ECN M111-4260 (released 12/29/2011) which was previously removed for clarification of the intended use and subsequent 501(K) approval.

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.

Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.

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

Potential carryover issue that can can cause shortened APTT clotting times on the instrument.

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