FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
- Recall number
- Z-0032-05
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
- Status
- Terminated
- Initiated
- 2004-07-09
- Posted
- 2004-10-22
- Terminated
- 2005-09-13
- Reason
- possible error calculating valve area with the AXIOM Sensis
- Root cause
- Other
- Action
- The recalling firm has issued a Customer Advisory to the affected customers per Update Instructions AX053/04/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.
- Quantity
- 143 units
- Distribution
- The product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV.
- Lot, serial or model codes
- Serial numbers: 1155, 6002, 6006-6014, 6016, 6018-6021, 6023-6025, 6027-6053, and 6100-6125. Model number 66 34 641 involves the following serial numbers: 4001-4008 and 4050-4056. Model number 66 34 658 involves the following serial numbers: 8001-8003, 8006-8007, 8009-8010, and 8050-8055. Model number 66 48 161 involves the following serial numbers: 11001-11014, 11016, 11018, and 11050-11054.
- 510(k) numbers
- ["K020440"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- 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