—#181228

Product

Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K181560
Affected lot / code info: Serial Numbers: 12425, 109, 10063, 12946

Why it was recalled

Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector

Root cause (FDA determination)

Process design

Action the firm took

Siemens Healthcare issued A Customer Safety Advisory Notice dated 4/20/20 via AX030/20/S. Letter states reason for recall, health risk and action to take: We strongly recommend that you do not disconnect the main unit from the monitor trolley when the system displays the system error message Err 16305 / 80: Confirm this error and repeat your last action until the problem has been corrected by a service engineer. Contact our service organization at 1-800-888-7436. Siemens is currently developing a solution to eliminate the root cause of this problem.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distributions.

Timeline

Recall initiated: 2020-04-20
Posted by FDA: 2020-05-04
Terminated: 2021-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181228. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.