Cios Alpha, 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 Recall Z-2887-2020 · Posted None
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2020-07-30
Date Terminated2021-05-20
Product Quantity329 units in total
Reason for Recall
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).
Firm Action
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 [email protected].
Root Cause
Device Design
Distribution Pattern
US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.