Axiom Sensis. Programmable Diagnostic Computer
FDA device recall Z-0979-03 · posted 2003-07-03 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- software problem - erroneous results or system crashes
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 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.
- Date initiated
- 2003-02-28
- Date posted
- 2003-07-03
- Date terminated
- 2004-04-08
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEWCOR (K020440) | Siemens Medical Systems, Inc. | 2002-12-03 |