Z-1959-2020Class II

Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 -

Name: Z-1959-2020 Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 -
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 Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide... 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-1959-2020
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 Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: 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: 46 units
Distribution: US Nationwide distributions.
Product codes and lots: Serial Numbers: 50124 50135 50131 50171 50129 50032 50033 50048 50050 50051 50073 50075 50081 50088 50098 50107 50109 50111 50120 50196 50102 50180 50136 50185 50096 50155 50091 50130 50127 50077 50078 50134 50122 50101 50092 50094 50166 50049 50192 50161 50125 50128 50132 50079 50160 50030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1959-2020
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

K181550Class IICios SpinSiemens Medical Solutions USA, Inc. / cleared 2018-10-30

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)