Z-2848-2020Class II

Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194...

Name: Z-2848-2020 Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194...
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-07-14
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-07-14 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system... on 2020-07-14. FDA classified it as Class II and gives the reason as "Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of...". 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-2848-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-14
Posted: 2020-08-22
Terminated: 2021-07-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 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: Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of imaging functionality.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to affected customers via AX013/20/S dated July 14, 2020, The letter states reason for recall, health risk and action to take: We advise urgently to cease the use of the hot plugging feature until the pending hardware update AX014/20/S has been completed. Siemens will correct the hardware error via Update Instruction AX014/20/S in which a Siemens Service Engineer will replace the main control D80. Service organization will contact you shortly to arrange a date to performthis corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Acknowledge Receipt of this Safety Advisory Notice.
Quantity in commerce: US: 282 units; OUS: 1363
Distribution: Nationwide
Product codes and lots: S-N Affected systems: 10xxx: 10001; 10003; 10010 10027; 10029 10031; 10033 10040; 10042 10045; 10048 10052; 10054 10110; 10112 10119 11xxx: 11000 11004; 11006 11028; 11030 11101; 11103 11183; 11185 11205; 11207 11372; 11374 11387; 11600 11608 12xxx: 12000 12014; 12016 12024; 12026 12045; 12047 12052; 12054; 12200 12207; 12301 12493; 12495 12505; 12507 12522; 12524 12550; 12552 12571; 12573; 12575 12610; 12612 12746; 12800 12803; 12805 12811; 12813 12889; 12891 12959; 12961 12973; 12975 12999 13xxx: 13000 13085; 13087; 13088; 13092; 13103 13105; 13114; 13121 4xxxx: 416; 40000; 40001; 40003 40021; 40030; 40038; 40070 5xxxx: 50001 50053; 50055; 50075 Expanded Recall: 11143, 12490

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2848-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2848-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22

Product code OWB

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)