TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31

FDA device recall Z-2275-2013 · posted 2013-09-25 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular Us Sales, Llc

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

OUG

Quantity affected

21 units

Distribution

Worldwide Distribution - USA including NY and PA and internationally to Australia, Brazil, Canada, Germany, Hong Kong, Japan, Sweden.

Date initiated

2013-08-19

Date posted

2013-09-25

Date terminated

2014-04-17

Location

Wayne, NJ