TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor)

FDA device recall Z-1437-06 · posted 2006-08-30 · Terminated

Recall details

Recalling firm

Radiometer America Inc

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

KLK

Quantity affected

9 monitors were distributed.

Distribution

Nationwide

Date initiated

2005-02-02

Date posted

2006-08-30

Date terminated

2012-05-09

Location

Westlake, OH