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U.S. Department of Health and Human Services

Class 2 Device Recall Accessory Head Rest for Alphastar Operating Tables

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 Class 2 Recall
Accessory Head Rest for Alphastar Operating Tables
see related information
Date Posted October 16, 2008
Recall Status1 Terminated on April 16, 2009
Recall Number Z-0161-2009
Recall Event ID 49545
Product Classification Table, Operating-Room, Ac-Powered - Product Code FQO
Product Accessory Head Rest for Alphastar Operating Tables
Code Information USA Part Number 1130.67F0, No serial numbers
Recalling Firm/
Manufacturer
MAQUET Inc.
1140 Us Highway 22 Ste 202
Bridgewater, New Jersey 08807-2958
For Additional Information Contact Mr. Jamie Yieh
732-667-1896
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action 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.
Quantity in Commerce 88 units in US; 1884 units worldwide
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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