Class 2 Device Recall TCM4

• Date Initiated by Firm: February 02, 2005
• Date Posted: August 30, 2006
• Recall Status: Terminated on May 09, 2012
• Recall Number: Z-1437-06
• Recall Event ID: 35700
• Product Classification: Cutaneous Oxygen Monitor - Product Code KLK
• Product: TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor)
• Code Information: All Model #TCM4
• Recalling Firm/ Manufacturer: Radiometer America Inc; 810 Sharon Dr; Westlake OH 44145-1598
• For Additional Information Contact: 440-871-8900
• Manufacturer 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.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 9 monitors were distributed.
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.