Device Recall TCM4 의 리콜

Recall

35700

Class 2

Z-1437-06

2005-02-02

2006-08-30

Terminated

United States

2012-05-09

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46640

Alarm may be silenced- rapid switching, on and off, of the tcm4 monitor may cause the built-in acoustical alarm to remain silent when tripped.

The firm initiated a recall action for the suspect device with a letter dated 2/2/2005. During a site visit to the U.S. customers conducted by the firm''s Field Service reps, the reps informed the user/customers of this problem and requested that all use of the device be discontinued, pending the formulation of a more permanent solution. Beginning on 2/8/2005, a second site visit was made to the same user/customers, at which time, the affected units were upgraded with operating software version 2.12. The firm''s recall/corrective action was scheduled for completion by 3/1/2005.