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U.S. Department of Health and Human Services

Class 2 Device Recall Alphastar

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 Class 2 Recall
Alphastar
see related information
Date Posted November 05, 2008
Recall Status1 Terminated on January 12, 2010
Recall Number Z-0188-2009
Recall Event ID 49448
Product Classification Table, Operating-Room, Ac-Powered - Product Code FQO
Product Maquet Alphastar 1132.01AX/BX, 1132.02AX/BX, and 1132.03AX/BX Universal Operating Table
Code Information ALPHASTAR 1132.01AX/BX up to serial number 871; ALPHASTAR 1132.02AX/BX up to serial number 22; ALPHASTAR 1132.03AX/BX up to serial number 31.
Recalling Firm/
Manufacturer
MAQUET Inc.
1140 US Highway 22
Bridgewater, New Jersey 08807-2958
For Additional Information Contact Jamie Yieh
732-667-1896
Manufacturer Reason
for Recall
Table tilts: The Alphastar Surgical Table piston rod head may break and cause a full inclination of the table top during Trendelenberg positioning if there is insufficient lubrication.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Equipment Maintenance
Action Maquet sent Recall Notification letters to all customers on September 16, 2008 by Federal Express. Letters inform customers of the potential problem with the Alphastar tables, a description of the failure and hazards involved. Hospitals are asked to confirm whether yearly maintenance by an authorized technician have been performed. If preventive maintenance has not been performed, customers are requested to contact their Maquet Service rep. A Customer Service Response form is included and customers are to complete if to acknowledge whether of not the facility is still in possession of an affected table. If so, the model number, serial number and facility name & address is to be completed so that Maquet reps can visit the facility and perform the corrective action.
Quantity in Commerce 141 in US
Distribution Nationwide
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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