Health product recall

Battery Mobile X-Ray Systems Soltus

Last updated

Summary

Product
Battery Mobile X-Ray Systems Soltus
Issue
Medical devices - Performance
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

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe