Axiom Aristos MX/VX. Model number 58 95 003
FDA device recall Z-0989-05 · posted 2005-07-13 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- potential issue (system may lock up) when repeating patient registrations
- Action taken
- The recalling firm issed a Customer Advisory Letter via certified mail to their cutomers informing them of the problem and information for the workaround to prevent problems for occurring until the software is upgraded.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 72 units
- Distribution
- Nationwide. The products were shipped to hospitals in AZ, CA, CO, FL, GA, IL, IN, KS, KY, ME, MI, MO, NC, NE, NJ, NY, OK, PA, TN, TX, UT, VA, WA, and WI.
- Date initiated
- 2005-06-10
- Date posted
- 2005-07-13
- Date terminated
- 2006-08-30
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) (K013826) | Siemens Medical Systems, Inc. | 2002-02-01 |