FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Sensis. Programmable Diagnostic Computer
- Recall number
- Z-0979-03
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Sensis. Programmable Diagnostic Computer
- Status
- Terminated
- Initiated
- 2003-02-28
- Posted
- 2003-07-03
- Terminated
- 2004-04-08
- Reason
- software problem - erroneous results or system crashes
- Root cause
- Other
- Action
- The recalling firm issued a Customer Safety Advisory Letter to their customers. The letter instructed the customer to insert the letter into their operator''s manual and that updated software would be released in May 2003.
- Quantity
- 4 units
- Distribution
- The product was shipped two medical facilities in MA and MI and two units were used as demonstration units by the recalling firm.
- Lot, serial or model codes
- Part numbers 6623974 and 6634633. Serial numbers 06011, 06012, 06018, and 02016.
- 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