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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Product Detail

Product Description TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025 www.elotouch.com Manufacturer: Tyco Electronics Brand Name: Elo Touch Systems Made in China Tegris system (1703.01) MAQUET GmbH & Co. KG Kehler Strabe 31 76437 Rastatt, Germany OR Table Module (1703.71) MAQUET GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Designed to be used as the central operating system in an operating room. The integration system has two main functions. -recording and distribution of images and videos -interaction with medical and non-medical devices. The system has a modular design and comprises the basic units as well as s various optional modules,which may be used or integrated in conjunction with the basic unit. TEGRIS is operated using a touchscreen. Medical devices that can be operated by TEGRIS include OR tables an OR lights. In the case of OR tables and OR lights, the main functions of these devices may be separated, e.g. adjustment of OR tables or switching the OR lights on.off. TEGRIS has no effected on the primary operating functions of the original control device. TEGRIS does not provide any other functions in addition to these primary operating functions. The purpose of TEGRIS namely the central operation of these various devices, is dependant on the individual devices. Please refer to the operating instructions of the individual devices for instructions. The integrated surgical safety checklist is a raft and must be modified to meet local requirements and approved by the User. TEGRIS is intended for short-term use pursuant to Appendix IX of the Directive 93/42/EEC of medical products in medical rooms in accordance with Group 1 and 2 VDR 0100-710, providing, among other things, protection against electric shock and connections for potential equalization lines. Intended for the following users: medical experts
Recall Number Z-2275-2013
Classification Class II
Code Info Class 1 exempt Device Listing #D122038 Tegris Base System 1703.01X0 OR TAblet Module 1703.71A0 Secondary 19" touchscreen - part number 1707.05A0 The above product is affected only when used in combination with Tegris base system 1703.01X0 OR Table Control 1703.71A0
Product Distributed Qty 21 units
Reason For Recall MAQUET has identified a potential issue that might occur because of the lack of an emergency stop button on a secondary touch screen display on the TEGRIS System.

Event Detail

Event Id 66051
Product Type Devices
Status Ongoing
Recalling Firm Maquet Cardiovascular Us Sales, Llc
City Wayne
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including NY and PA and internationally to Australia, Brazil, Canada, Germany, Hong Kong, Japan, Sweden.
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