Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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.