Recall Z-0992-2013 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system
| Date | Mar 25, 2013 (initiated Nov 26, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090745 | ARTIS ZEE / ZEEGOS WITH SW VC14 Siemens Medical Solutions USA, Inc., Jun 18, 2009 |