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Luminos drf max, mobilett elara max, ysio max and ysio x.pree

Official notice

5 Jul 2024

MediumHealth Canada

An official Health Canada notice concerns Luminos drf max, mobilett elara max, ysio max and ysio x.pree. Siemens Healthineers was informed by the detector manufacturer that magnetic connectors may have been supplied as spare parts for portable detectors. If magnetic connection units are installed, a permanent (static) magnetic field is generated that exists independently of the operation of the detector. This can affect the function of implantable electronic devices such as pacemakers or implantable defibrillators if a minimum distance of >5 cm from the implanted device is not maintained. Recall Start Date: June 18, 2024 Published 2024-07-05.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75792

Official notice

2024-07-05

The hazard

Siemens Healthineers was informed by the detector manufacturer that magnetic connectors may have been supplied as spare parts for portable detectors. If magnetic connection units are installed, a permanent (static) magnetic field is generated that exists independently of the operation of the detector. This can affect the function of implantable electronic devices such as pacemakers or implantable defibrillators if a minimum distance of >5 cm from the implanted device is not maintained. Recall Start Date: June 18, 2024

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

75792

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Affected products

Product 1

Affected products - YSIO Max, Lot or serial number - VF10K_SP05 VF10K VF11H VE10ZA VF10F_HF05, Model or catalog number - 10762470

Product 2

Affected products - Luminos dRF Max, Lot or serial number - VF10K_SP05, Model or catalog number - 10762471

Product 3

Affected products - MOBILETT Elara Max, Lot or serial number - VF10K, Model or catalog number - 11107444

Product 4

Affected products - YSIO X.Pree, Lot or serial number - VA10F_HF03, Model or catalog number - 11107464

Risk / hazard

Siemens Healthineers was informed by the detector manufacturer that magnetic connectors may have been supplied as spare parts for portable detectors. If magnetic connection units are installed, a permanent (static) magnetic field is generated that exists independently of the operation of the detector. This can affect the function of implantable electronic devices such as pacemakers or implantable defibrillators if a minimum distance of >5 cm from the implanted device is not maintained. Recall Start Date: June 18, 2024

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 Mobilett Elara Max Ysio Max And Ysio X.pree.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75792

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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