Recall Z-0374-2014 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
| Date | Nov 26, 2013 (initiated Sep 3, 2013) |
| Status | Terminated |
| Reason | A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality. |
| Root cause | Software design |
| Action | Siemens Healthcare sent a Field Safety Notice dated September 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Field Safety Notice to any new users and provide the new owner information to Siemens Healthcare. Customers were asked to send back the attached form confirming receipt of the Field Safety Notice. Customers with questions should call 610-850-4634. For questions regarding this recall call 610-219-6300. |
| Quantity | 357 |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Canada. |
| FDA record | Open on fda.gov |