Recall Z-2275-2013 ยท OUG Medical Device Data System
Maquet Cardiovascular Us Sales, Llc
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 Stra
| Date | Sep 25, 2013 (initiated Aug 19, 2013) |
| Status | Terminated |
| Reason | 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 | 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 rec |
| Quantity | 21 units |
| Distribution | Worldwide Distribution - USA including NY and PA and internationally to Australia, Brazil, Canada, Germany, Hong Kong, Japan, Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.