Ysio Radiography X-Ray System - Full Motorized (2020-02-10)

Starting date:

February 10, 2020

Posting date:

February 28, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Laceration Hazard

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72435

Last updated: 2020-03-06

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  Reason
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  Affected products

Affected Products

Ysio Radiography X-Ray System - Full Motorized

Reason

Siemens is notifying users of Ysio Fully Automated System with software version VB10 about a potential malfunction of the motor controller.

In rare cases, the system processes incorrect internal values for the position of its ceiling tube stand. If in this situation the user then activates a longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the system's controls may (depending on the values being processed) initiate a ""correction"" of the tube stand position, resulting in an unexpected movement.

Affected products