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Luminos drf max, uroskop omnia max, multitom rax

Official notice

11 Apr 2022

MediumHealth Canada

An official Health Canada notice concerns Luminos drf max, uroskop omnia max, multitom rax. 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 Published 2022-04-11.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64068

Official notice

2022-04-11

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64068

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Affected products

Product 1

Affected Products - LUMINOS DRF MAX, Lot or Serial Number - More than 10 numbers, contact manufacturer., Model or catalog number - 10762471

Product 2

Affected Products - UROSKOP OMNIA MAX, Lot or Serial Number - More than 10 numbers, contact manufacturer., Model or catalog number - 10762473

Product 3

Affected Products - MULTITOM RAX, Lot or Serial Number - 11109, 11017, 11106, 11107, 11111, 11108, Model or catalog number - 10860700

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Siemens, Luminos Drf Max Uroskop Omnia Max Multitom Rax.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64068

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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