Public recall detail

Ingenia 3.0T

2024-09-13

medium
Recall Safety notice
Quick summary

Quick summary: Ingenia 3.0T. Date: 2024-09-13.

Recommended action

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

Recall details

Quick summary: Ingenia 3.0T. Date: 2024-09-13.

Official details

Affected product details

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

BrandPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ProductIngenia 3.0T
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76041

Affected products

ProductIngenia 3.0T
Lots/n: 34055
Model782103
Serial numbers/n: 34055
DescriptionIngenia 3.0T

Issue

Philips has identified an issue in the MR system patient support where the integrated radio frequency (IRF) carrier assembly screws may come loose and protrude beyond the surface. This could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop movement. The IRF carrier, a component of the patient support within the MR system, supports the tabletop where the patient lies. As the patient moves into the MRI tunnel, the tabletop, supported by the IRF carrier, forms a container for positioning the posterior coil. Recall start date: September 4, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76041
Background{}
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
AudiencesHealthcare
Source updated2024-09-13

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

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