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.
This recall has been terminated (originally issued July 30, 2020).
- Recall Initiated
- July 30, 2020
- Terminated
- May 20, 2021
- Recall Number
- Z-2887-2020
- Quantity
- 329 units in total
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
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).
Distribution
US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.
Lot / Code Info
Cios Alpha (VA20)- 10308191 Cios Alpha (VA30)- 11105200
Root Cause
Device Design
Action Taken
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.