Accessory Head Rest for Alphastar Operating Tables

FDA device recall Z-0161-2009 · posted 2008-10-16 · Terminated

Recall details

Recalling firm

MAQUET Inc.

Reason for recall

During installation or cleaning there is a risk of crushing the finger by handling the head rest in the area of the gas strut while simultaneously actuating the release lever.

Action taken

Urgent Device Correction letters were sent beginning September 26, 2008 via Fed Ex. Letters identified the potential for finger crush in conjunction with the head rest. Proper operating instructions are provided as well as a warning sticker to be applied to the head rest indicating proper positioning. All letters included a customer response form to be completed by each institution. Information requested is: that device correction letter has been read and instructions followed; that the corrected operating instructions have been received; that the warning sticker has been properly placed on the headrest, or that they do not have the head rest identified in the device correction letter. Questions should be addressed to USA Maquet Inc at 1-888-627-8383 #1.

Root cause

Other

Status

Terminated

Product code

FQO

Quantity affected

88 units in US; 1884 units worldwide

Distribution

Nationwide Distribution

Date initiated

2008-09-26

Date posted

2008-10-16

Date terminated

2009-04-16

Location

Bridgewater, NJ