Recall Z-0620-2009 ยท FWZ Operating Room Accessories Table Tray
MAQUET Inc.
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 swi
| Date | Jan 15, 2009 (initiated Dec 8, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 587 units total (54 units in US) |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.