Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical confi
FDA device recall Z-0992-2013 · posted 2013-03-25 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- In the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis zeego system with software revision VC14, VC20 and VC21 in conjunction with a specific technical configuration which cannot be completely executed.
- Action taken
- Siemens sent an Urgent Customer Information letter dated November 8, 2012 to affected consignees. The letter notified consignees of the issue and informed them the update AX039/12/S would be started and affected systems would be checked and corrected if required. Customers were instructed that they would be contacted to arrange a date for checking their system. For questions regarding this recall call 610-219-6300.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 52
- Distribution
- Nationwide Distribution including AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, LA, MD, MI, MO, NC, NH, OR, PA, SD, TN, TX, WA and WI and Puerto Rico.
- Date initiated
- 2012-11-26
- Date posted
- 2013-03-25
- Date terminated
- 2013-12-24
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS ZEE / ZEEGOS WITH SW VC14 (K090745) | Siemens Medical Solutions USA, Inc. | 2009-06-18 |