Maquet Recalls TEGRIS System Due to Missing Emergency Stop Button
Maquet is recalling 21 TEGRIS systems because a secondary touch screen display lacks an emergency stop button.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a missing safety feature (emergency stop button) where no injuries or illnesses have been reported, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 21 units of the TEGRIS system. The recall is due to a potential issue where the secondary touch screen display lacks an emergency stop button.
The TEGRIS system is a central operating system for operating rooms that records and distributes images and videos and interacts with medical and non-medical devices. It is operated using a touchscreen and can control devices such as operating room tables and lights. The affected units are the Tegris Base System (1703.01X0) and OR Tablet Module (1703.71A0) used in combination with the Secondary 19" touchscreen (part number 1707.05A0).
The affected units were distributed worldwide, including in the United States (New York and Pennsylvania) and internationally to Australia, Brazil, Canada, Germany, Hong Kong, Japan, and Sweden. The source text does not specify instructions for consumers or healthcare providers on how to proceed with the recall.
The recalled product
- 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.co
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
- Affected units
- 21
Distribution
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