Z-0188-2009
Maquet Alphastar 1132.01AX/BX, 1132.02AX/BX, and 1132.03AX/BX Universal Operating Table
Maquet Cardiovascular Us Sales, LLC / initiated 2008-09-16 / Terminated / root cause: manufacturing process
MAQUET Inc. began a recall of Maquet Alphastar 1132.01AX/BX, 1132.02AX/BX, and 1132.03AX/BX Universal Operating Table on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0188-2009
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Maquet Cardiovascular Us Sales, LLC
- Product
- Maquet Alphastar 1132.01AX/BX, 1132.02AX/BX, and 1132.03AX/BX Universal Operating Table
- Product code
- FQO Table, Operating-Room, Ac-Powered
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- 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
- Product codes and lots
- 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.
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