Class 2 Device Recall Maquet

• Date Initiated by Firm: August 19, 2013
• Date Posted: September 25, 2013
• Recall Status: Terminated on April 17, 2014
• Recall Number: Z-2275-2013
• Recall Event ID: 66051
• Product Classification: Medical Device Data System - Product Code OUG
• Product: 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
• Code Information: 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
• Recalling Firm/ Manufacturer: Maquet Cardiovascular Us Sales, Llc; 45 Barbour Pond Drive; Wayne NJ 07470
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: Maquet sent an Urgent Medical Device Recall Letters/Field Action Response Forms dated August 19, 2013, via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were informed that a MAQUET authorized service technician would contact them to arrange an appointment to equip their system with a second emergency stop button that would be located in close proximity to the secondary touch screen. Customers were instructed to complete and return the enclosed Field Action Response Form acknowledging their receipt and understanding of the communiction by emailing a scanned copy to FieldActions@maquet.com or via fax at 973-807-1658. Customers with questions were asked to contact their MAQUET representative or MAQUET Technical Support at 888-627-8383, option 3. For questions regarding this recall call 973-709-7361.
• Quantity in Commerce: 21 units
• Distribution: Worldwide Distribution - USA including NY and PA and internationally to Australia, Brazil, Canada, Germany, Hong Kong, Japan, Sweden.
• 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.