Z-2275-2013Class II

TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG...

Name: Z-2275-2013 TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2013-08-19
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2013-08-19 / Terminated / root cause: design

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt... on 2013-08-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2275-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-19
Posted: 2013-09-25
Terminated: 2014-04-17
Recalling firm: Maquet Cardiovascular Us Sales, LLC
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
Product code: OUG Medical Device Data System
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.
Root cause tag: design
FDA root 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 [email protected] 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2275-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2275-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-25

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)