—#112203

Product

Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010942
Affected lot / code info: Model number 5756130 -- serial numbers 6076, 6078, 6080, 6081, and 6082.

Why it was recalled

Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, the motor may become disconnected and the entire table assembly may fall on the floor.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Siemens sent a Update instructions letter dated April 2012, to all affected customers. The safety instruction letter identified the product the problem and the action needed to be taken by the customer. The update has been completed successfully. The customer has been informed of the benefits of improvements resulting from this update. Further questions please call (610) 219-4834.

Recalling firm

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

Distribution

Distribution pattern: Nationwide distribution: USA including states of: IN, MI, MS, TN and TX.

Timeline

Recall initiated: 2012-04-30
Posted by FDA: 2012-09-10
Terminated: 2012-09-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112203. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.