Foot switch, Part Number 1009.81. Maquet GmbH & Co. KG, 76437 Rastatt, Germany. The foot switches in the 1009.8 1 series

FDA device recall Z-0620-2009 · posted 2009-01-15 · Terminated

Recall details

Recalling firm

MAQUET Inc.

Reason for recall

A bearing point of the pedal of the foot switch may come loose. With continued use of the foot switch, one or both springs beneath the pedal can fall out of their mounting, and it is possible the pedal comes to rest on the switch causing an unintended motion of the operating table during patient use.

Action taken

An Urgent Device Correction letter (with an enclosed Customer Response form) was sent via Federal Express on Monday, December 8, 2008 to all customers who had received tables. Customers were notified in the letter of the problem and actions to be taken including not to use any affected foot pedal for safety reasons. In addition, customers were instructed to complete and return the Customer Response Form via fax (732-667-1903) to Maquet Inc. Please call USA Maquet, Inc. at toll free number 1-888-627-8383 #1 (then select the option for Surgical Workplace products) for questions.

Root cause

Device Design

Status

Terminated

Product code

FWZ

Quantity affected

587 units total (54 units in US)

Distribution

Worldwide Distribution.

Date initiated

2008-12-08

Date posted

2009-01-15

Date terminated

2012-06-18

Location

Bridgewater, NJ