Maquet Alphastar 1132.01AX/BX, 1132.02AX/BX, and 1132.03AX/BX Universal Operating Table

FDA device recall Z-0188-2009 · posted 2008-11-05 · Terminated

Recall details

Recalling firm

MAQUET Inc.

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.

Action taken

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.

Root cause

Equipment maintenance

Status

Terminated

Product code

FQO

Quantity affected

141 in US

Distribution

Nationwide

Date initiated

2008-09-16

Date posted

2008-11-05

Date terminated

2010-01-12

Location

Bridgewater, NJ