Health product recall

LUMINOS DRF MAX, UROSKOP OMNIA MAX, MULTITOM RAX

Last updated

Summary

Product
LUMINOS DRF MAX, UROSKOP OMNIA MAX, MULTITOM RAX
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

LUMINOS DRF MAX

More than 10 numbers, contact manufacturer.

10762471

UROSKOP OMNIA MAX

More than 10 numbers, contact manufacturer.

10762473

MULTITOM RAX

11109, 11017, 11106, 11107, 11111, 11108

10860700

Issue

Siemens Healthcare will be distributing new operator's manuals to affected customers which are needed for the upcoming software upgrade to VF11.

5 cautions were added to the manual.
Caution 1 (added two sentences to already existing caution): cause: Patient falls during standing 3d

Remedy: Always use the 3d ortho stand for standing 3d studies. Aid patient in climbing onto the 3d ortho stand. Make sure that the patient is stable enough to stand for the entire examination

Caution 2 cause: Operator or patient trips over the foot switch cable or the foot switch itself

Remedy: position the foot switch and the associated cable on the floor so that nobody trips.

Caution 3: cause: the detector holder is not securely fastened

Remedy: make sure the detector holder is securely fastened

Caution 4: cause: riding on wheeled accessories

Remedy: Do not ride or allow anyone else to stand, sit or ride on wheeled accessories while they are
being rolled.

Caution 5: cause: unauthorized access to the system

Remedy: the hospital is responsible for network security at the site. Set up firewalls and user account password protections. Do not allow users to change configuration files. Update virus protection software as required.

 

Siemens Healthcare will be distributing new operator's manuals to affected customers which are needed for the upcoming software upgrade to VF11.

Caution: cause: patient cannot maintain position or becomes unconscious
Remedy: check that the patient is physically able to hold the examination position, especially when standing. Choose a different position or use positioning aids for immobilizing weak or very unstable patients.
Caution cause: unauthorized access to the system
remedy: The hospital is responsible for network security at the site. set up firewalls.

 

Siemens Healthcare will be distributing new operator's manuals to affected customers which are needed for the upcoming software upgrade to VF11. This update delivers a new manual to customers to be able to use the upcoming software version VF11. A caution was added to the manual to prevent unauthorized access to the system.

 

Recall start date: Apr 5, 2022

Additional information

Details
Original published date: 2022-04-13
Alert / recall type
Health product recall
Category
Health product - Medical device - Radiology
Companies

Siemens Healthcare Gmbh

Henkestr. 127, Erlangen

Germany, 91052

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64068