FDA Medical Device Recalls (openFDA)
Radiometer America Inc: TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)
- Recall number
- Z-1453-06
- Recalling firm
- Radiometer America Inc
- Product
- TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)
- Status
- Terminated
- Initiated
- 2006-04-07
- Posted
- 2006-08-29
- Terminated
- 2012-04-25
- Reason
- System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further.
- Root cause
- Other
- Action
- The firm began a recall/corrective action in response to this component defect on 4/7/2006, at which time, the firm issued a Field Action Notes memo (915-234). The firm is having their representatives: 1) assure that the use of the CompactFlashcards manufactured by Simple Tech has been discontinued at each customer location; 2) Replaace the CompactFlash card in all basic Units, 391-876, of R0036 through R0043; and 3) replace any spare part #914-698, which has been installed in Basic Units, 391--876, below R0036. Once completed, the firm has supplied their customers with a TELEFAX form to be completed, signed and dated by each customerand faxed back to Radiometer Medical ApS. The form documents that the instructions provided in theField Action Notes have been followed and that the necessary component replacements have been completed. The firm anticipates that the necesary corrective action will be completed by 7/1/2006.
- Quantity
- 61 in U.S. 7 in Canada
- Distribution
- Worldwide-The recalled product was distributed to customers throughout the U.S. and Canada.
- Lot, serial or model codes
- TCM4 - Base Unit : Model: 391-876, Lot Numbrs R0036 thru R0043 (both inclusive). CompactFlash cards - Component: Model #914-698
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KLK
- Firm FEI
- 1523456
- Firm city
- Westlake
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28