—#154432

Product

Artis zee, Angiographic x-ray system

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K073290
Affected lot / code info: Device Model Numbers: 10280959, 10094137, 10094141, Serial numbers: 160449 147208, 153744

Why it was recalled

Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Siemens mailed a Customer Safety Advisory Notice (CSAN) AX017/17/S to affected customers on 03/28/2017 to inform them of the corrective action that will be performed to prevent a possible hazard to persons and equipment. The notice also explained the underlying issue, the impact on system operation, potential risk to patients and actions they are taking to correct the issue.

Recalling firm

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

Distribution

Distribution pattern: Distributed to: VA, CA, WI

Timeline

Recall initiated: 2017-03-28
Posted by FDA: 2017-03-30
Terminated: 2017-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154432. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.