PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 2, 2020 Initiated: July 14, 2020 #Z-2848-2020

Product Description

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

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.

Details

Units Affected
US: 282 units; OUS: 1363
Distribution
Nationwide
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by Siemens Medical Solutions USA, Inc. Units affected: US: 282 units; OUS: 1363.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 2, 2020. Severity: Moderate. Recall number: Z-2848-2020.