—#121793

Product

(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K062623, K081722, K101491, K111292
Affected lot / code info: Model numbers: 10094200, 10094910, 10281013, 10281163, 10502200

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Canada.

Timeline

Recall initiated: 2013-09-03
Posted by FDA: 2013-11-26
Terminated: 2015-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121793. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.