Health product recall

Battery Mobile X-Ray Systems Soltus

Last updated

Summary

Product
Battery Mobile X-Ray Systems Soltus
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Battery Mobile X-Ray System Soltus 450

SLS000191
SLS000192
SLS000193

10451

Battery Mobile X-Ray System Soltus 500

SLS000131
SLS000130

10501

Issue

There have been incidents of erratic movement involving Soltus mobile x-ray units. Shis problem is caused by a software problem: the backwards high-speed movement is produced due to a bug in the movement control loop while the bumper is activated, the user pushes "manually" the mobile, and then at a certain moment the bumper is mechanically released. In this situation, the reference values for the movement control loop were not correct, and the unit moved backwards and rotates in high speed.

Recall start date: November 18, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Sociedad Espanola De Electromedicina Y Calidad, S.A. (Sedecal)

Poligono Industrial Rio De Janeiro, Algete, Madrid, Spain, 28110

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72336

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