Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1437-06 · Posted 2006-08-30

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeKLK
Date Initiated2005-02-02
Date Terminated2012-05-09
Product Quantity9 monitors were distributed.

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.

Firm Action

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

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑