—#85636

Product

Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033. Indended use: X-Ray, Fluoroscopic, Image-intensified.

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K960266
Affected lot / code info: Model Number 4466033, Serial Numbers: 1506, 1528, 1529, 1539, 1544, 1568, 1633, 1821, 1841, 1864, 1877, 2020, 2023, and 2126.

Why it was recalled

possible injury to hand/fingers

Root cause (FDA determination)

Device Design

Action the firm took

Siemens Medical Solutions USA, Inc. issued a "Customer Safety Advisory Notice" dated September 11, 2009 to inform customers of the potential hazard to patients when using the Siregraph CF system. For further information, contact Siemens at 1-610-448-4500.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- FL, IL, MI, PA and TX.

Timeline

Recall initiated: 2009-09-23
Posted by FDA: 2009-11-12
Terminated: 2010-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85636. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.