TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor)
This recall has been terminated (originally issued August 30, 2006).
- Company
- Radiometer America Inc
- Recall Initiated
- February 2, 2005
- Posted
- August 30, 2006
- Terminated
- May 9, 2012
- Recall Number
- Z-1437-06
- Quantity
- 9 monitors were distributed.
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide
Lot / Code Info
All Model #TCM4
Root Cause
Other
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.