AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637
FDA device recall Z-1446-04 · posted 2004-09-14 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 234 units
- Distribution
- The product was shipped to 43 medical facilities nationwide and one government account in KY.
- Date initiated
- 2004-05-17
- Date posted
- 2004-09-14
- Date terminated
- 2005-04-11
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEWCOR (K020440) | Siemens Medical Systems, Inc. | 2002-12-03 |