Z-2887-2020Class II

Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray...

Name: Z-2887-2020 Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray...
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-07-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-07-30 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of 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... on 2020-07-30. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2887-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-30
Posted: 2020-08-26
Terminated: 2021-05-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: 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.
Product code: OWB Interventional Fluoroscopic X-Ray System
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).
Root cause tag: design
FDA root cause: Device Design
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].
Quantity in commerce: 329 units in total
Distribution: US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.
Product codes and lots: Cios Alpha (VA20)- 10308191 Cios Alpha (VA30)- 11105200

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2887-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2887-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-26
Z-2888-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-26

Product code OWB

K181560Class IICios AlphaSiemens Medical Systems USA, Inc. / cleared 2018-10-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)