Public recall detail

Luminos dRF Max, MOBILETT Elara Max, YSIO Max and YSIO X.Pree

2024-07-05

medium
Recall Safety notice
Quick summary

Quick summary: Luminos dRF Max, MOBILETT Elara Max, YSIO Max and YSIO X.Pree. Date: 2024-07-05.

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, MOBILETT Elara Max, YSIO Max and YSIO X.Pree. Date: 2024-07-05.

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, MOBILETT Elara Max, YSIO Max and YSIO X.Pree
IssueMedical devices - Device compatibility
Recall classType II
IdentificationRA-75792

Affected products

ProductYSIO Max
LotVF10K_SP05 VF10K VF11H VE10ZA VF10F_HF05
Model10762470
Serial numberVF10K_SP05 VF10K VF11H VE10ZA VF10F_HF05
DescriptionYSIO Max
ProductLuminos dRF Max
LotVF10K_SP05
Model10762471
Serial numberVF10K_SP05
DescriptionLuminos dRF Max
ProductMOBILETT Elara Max
LotVF10K
Model11107444
Serial numberVF10K
DescriptionMOBILETT Elara Max
ProductYSIO X.Pree
LotVA10F_HF03
Model11107464
Serial numberVA10F_HF03
DescriptionYSIO X.Pree

Issue

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Healthcare Industry
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-75792
Background{}
CompaniesSiemens Healthcare Gmbh Henkestr. 127, Erlangen, Germany, 91052
AudiencesGeneral public Healthcare Industry
Source updated2024-07-05

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

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