Radiometer America Inc TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor)
Brand
Radiometer America Inc
Lot Codes / Batch Numbers
All Model #TCM4
Products Sold
All Model #TCM4
Radiometer America Inc is recalling TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor) due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026