SIEMENS AXIOM Artis - AUTOMAP FUNCTION
FDA device recall Z-1108-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Error appears in the AUTOMAP function, Module 2, when PERISTEEPING or PERIVISION is activated simultaneously that causes system to crash.
- Action taken
- The recalling firm sent recall letter to their customers informing them of the software problem. The customers were informed that a Siemens Service Representative will visit each location to deactivate Module 2 of the AUTOMAP function per Update AX023/04S.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 127 units
- Distribution
- The recalled product has been distributed throughout the United States, such as: AK, AL, AZ, CA, DC, FL, GA, IA, IL, IN, KY, LA, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI,
- Date initiated
- 2004-06-02
- Date posted
- 2004-07-20
- Date terminated
- 2004-10-21
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM (K010721) | Siemens Medical Corp. | 2001-03-30 |