—#183129

Product

Cios Spin, Image-Intensified Fluoroscopic X-Ray System 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: K181550
Affected lot / code info: Cios Spin (VA30)- 10308194

Why it was recalled

Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).

Root cause (FDA determination)

Device Design

Action the firm took

Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 27, 2020 to customers. This letter explains the issue that may arise while using the system. The letter instructs users to 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 to avoid potential electrical shock until pending hardware update has been completed. Our service organization will contact you for an appointment to perform the corrective action. Please feel free to contact our service organization at 1-800-888-7436 for an earlier appointment.This letter asks users to acknowledge receipt of the consignee letter by signing and returning the document. If you have any further questions, call 610-219-4834 or rebecca.tudor@siemens-healthineers.com.

Recalling firm

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

Distribution

Distribution pattern: US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.

Timeline

Recall initiated: 2020-07-30
Terminated: 2021-05-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183129. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.