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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Foot switch

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  Class 2 Device Recall Maquet Foot switch see related information
Date Initiated by Firm December 08, 2008
Date Posted January 15, 2009
Recall Status1 Terminated 3 on June 18, 2012
Recall Number Z-0620-2009
Recall Event ID 50472
Product Classification Accessories, operating-room, table - Product Code FWZ
Product Foot switch, Part Number 1009.81. Maquet GmbH & Co. KG, 76437 Rastatt, Germany.

The foot switches in the 1009.8 1 series are accessory components which can be connected to certain MAQUET operating tables. Several of the table top adjustment motions (depending on the table and foot switch versions in use) can then be executed by the foot. The foot switch is equipped with rocker switches. The switching elements are used to initiate the table top functions.

Code Information Product manufactued between 8/2004 and 9/2008 may be affected: 1009.81A0, 1009.81A1, 1009.81A2, 1009.81A3, 1009.81B0, 1009.81B1, 1009.81B2, 1009.81C0, 1009.81C1, 1009.81D0, 1009.81D1, 1009.81D2, 1009.81D3, 1009.81D4, 1009.81E0, 1009.81E1, 1009.81E2, 1009.81E3, 1009.81F0, 1009.81F1, 1009.81F2, 1009.81F3, 1009.81G0, 1009.81G1 and 1009.81G2.
Recalling Firm/
Manufacturer		 MAQUET Inc.
1140 US Highway 22
Bridgewater NJ 08807-2958
For Additional Information Contact Jamie Yieh
732-667-1896
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 587 units total (54 units in US)
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC 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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