AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658
FDA device recall Z-0035-05 · posted 2004-10-22 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- possible error calculating valve area with the AXIOM Sensis
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 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.
- Date initiated
- 2004-07-09
- Date posted
- 2004-10-22
- Date terminated
- 2005-09-13
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEWCOR (K020440) | Siemens Medical Systems, Inc. | 2002-12-03 |