Recall – X-ray system incorrect position values lead to unexpected movement

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 3/25/2020
Class II

PRODUCT

Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.

  • Recall Number: Z-1501-2020

REASON

The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc on 2/10/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

81 US/ 308 worldwide

DISTRIBUTION

US Nationwide

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.