Public recall detail

LUMINOS DRF MAX, UROSKOP OMNIA MAX, MULTITOM RAX

2022-04-13

medium
Recall Safety notice
Quick summary

Quick summary: LUMINOS DRF MAX, UROSKOP OMNIA MAX, MULTITOM RAX. Date: 2022-04-13.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: LUMINOS DRF MAX, UROSKOP OMNIA MAX, MULTITOM RAX. Date: 2022-04-13.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSiemens Healthcare Gmbh
ProductLUMINOS DRF MAX, UROSKOP OMNIA MAX, MULTITOM RAX
IssueMedical devices - Software defect
Recall classType II
IdentificationRA-64068

Affected products

ProductLUMINOS DRF MAX
LotMore than 10 numbers, contact manufacturer.
Model10762471
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionLUMINOS DRF MAX
ProductUROSKOP OMNIA MAX
LotMore than 10 numbers, contact manufacturer.
Model10762473
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionUROSKOP OMNIA MAX
ProductMULTITOM RAX
Lot11109, 11017, 11106, 11107, 11111, 11108
Model10860700
Serial number11109, 11017, 11106, 11107, 11111, 11108
DescriptionMULTITOM RAX

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Radiology
CompaniesSiemens Healthcare Gmbh Henkestr. 127, Erlangen Germany, 91052
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64068
Background{}
CompaniesSiemens Healthcare Gmbh Henkestr. 127, Erlangen Germany, 91052
AudiencesGeneral public Health professionals Hospitals
Source updated2022-04-11

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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