Z-1957-2020Class II

Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile...

Name: Z-1957-2020 Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile...
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-04-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-04-20 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of 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... on 2020-04-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1957-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-20
Posted: 2020-05-04
Terminated: 2021-05-10
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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 tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 4 units
Distribution: US Nationwide distributions.
Product codes and lots: Serial Numbers: 12425, 109, 10063, 12946

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1957-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1957-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11
Z-1958-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11
Z-1959-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11

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)