FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637
- Recall number
- Z-1446-04
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637
- Status
- Terminated
- Initiated
- 2004-05-17
- Posted
- 2004-09-14
- Terminated
- 2005-04-11
- Reason
- Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.
- Root cause
- Other
- Action
- The recalling firm issued a Customer Safety Advisory to their customers via certified mail on 5/17/04 to inform them of the problem. The advisory provides Update Instructions AX031/04/S to prevent this problem from occurring until the software upgrade is installed to correct the problem.
- Quantity
- 234 units
- Distribution
- The product was shipped to 43 medical facilities nationwide and one government account in KY.
- Lot, serial or model codes
- Serial Numbers 1002, 1034, 1100-1253, 1300-1504
- 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