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U.S. Department of Health and Human Services

Class 2 Device Recall Alphastar

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 Class 2 Device Recall Alphastarsee related information
Date Initiated by FirmSeptember 16, 2008
Date PostedNovember 05, 2008
Recall Status1 Terminated 3 on January 12, 2010
Recall NumberZ-0188-2009
Recall Event ID 49448
Product Classification operating table - Product Code FQO
ProductMaquet 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.
FEI Number 3008355164
Recalling Firm/
Manufacturer		 MAQUET Inc.
1140 US Highway 22
Bridgewater NJ 08807-2958
For Additional Information ContactJamie 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		Equipment maintenance
ActionMaquet 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 Commerce141 in US
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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