—#151463

Product

SOMATOM Scope, Computed tomography x-ray system

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K151749
Affected lot / code info: Model # 10967666 Serial Number:59376 91766 91767 115456 115454 59380 77560 98840 77557 91758 59377 59378 115451

Why it was recalled

Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Siemens mailed on December 01, 2016 a Customer Safety Notice to affected customers to inform them of a corrective action that is being performed to prevent a possible hazard to persons and equipment. The notice explained the underlying issue, the effect the issue has on the system, the associated risks and actions they will take to correct the issue. In addition, customers will receive a Customer Safety Notice via Hand Delivery from the Siemens Customer Service Engineer at the scheduled appointment for the corrective installation.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Distributed to: IL IL GA SC SD OK NY MI IN MD AR

Timeline

Recall initiated: 2016-11-22
Terminated: 2017-05-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151463. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.