Public recall detail

Somatom Edge Products

medium
Recall Safety notice
Quick summary

Quick summary: Somatom Edge Products.

Recommended action

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

Recall details

Quick summary: Somatom Edge Products.

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
ProductSomatom Edge Products
IssueMedical devices - Quality
Recall classType II
IdentificationRA-63824

Affected products

ProductSomatom Edge Plus
LotNot applicable.
Model10267000
Serial numberNot applicable.
DescriptionSomatom Edge Plus
ProductSomatom Definition Edge System-Ct System
LotNot applicable.
Model10590000
Serial numberNot applicable.
DescriptionSomatom Definition Edge System-Ct System
ProductSomatom Definition As-Main Unit
LotNot applicable.
Model8098027
Serial numberNot applicable.
DescriptionSomatom Definition As-Main Unit
ProductSomatom Confidence-System
LotNot applicable.
Model10590100
Serial numberNot applicable.
DescriptionSomatom Confidence-System

Issue

Decreased head image quality on P46 systems after VB20 SP5 installation. This customer advisory notice provides a detailed error and workaround description. Recall start date: Jan 6, 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-63824
Background{}
CompaniesSiemens Healthcare Gmbh Henkestr. 127, Erlangen Germany, 91052
AudiencesGeneral public Health professionals Hospitals
Source updated2022-01-17

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

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