Public recall detail

Philips Achieva, Intera and Ingenia Systems

2024-01-17

medium
Recall Safety notice
Quick summary

Quick summary: Philips Achieva, Intera and Ingenia Systems. Date: 2024-01-17.

Recommended action

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

Recall details

Quick summary: Philips Achieva, Intera and Ingenia Systems. Date: 2024-01-17.

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.
ProductPhilips Achieva, Intera and Ingenia Systems
IssueMedical devices - Performance
Recall classType I
IdentificationRA-74922

Affected products

ProductAffected products
LotLot or serial number
ModelModel or catalog number/
Serial numberLot or serial number
DescriptionAffected products
ProductAchieva XR System-Main Unit
LotNot applicable.
ModelACHIEVA XR
Serial numberNot applicable.
DescriptionAchieva XR System-Main Unit
ProductAchieva 3.0T MRI System-Main Unit
LotNot applicable.
ModelACHIEVA 3.0T
Serial numberNot applicable.
DescriptionAchieva 3.0T MRI System-Main Unit
ProductIntera 1.5T MRI System-Main Unit
LotNot applicable.
ModelINTERA 1.5T
Serial numberNot applicable.
DescriptionIntera 1.5T MRI System-Main Unit
ProductAchieva 1.5T MRI System-Main Unit
LotNot applicable.
ModelACHIEVA 1.5T
Serial numberNot applicable.
DescriptionAchieva 1.5T MRI System-Main Unit
ProductIngenia 3.0T
LotNot applicable.
Model3.0T
Serial numberNot applicable.
DescriptionIngenia 3.0T

Issue

The quadrature body coil (QBC) seal adhesive may fail creating sharp edges that may come in contact with patients. The QBC seal may become loose as the patient table travels in a horizontal motion in and out of the system bore. The QBC seal (figure 1) is a rubber seal that is glued between the cone cover and QBC cover and functions to prevent sharp edges of the QBC cover from contacting patients during an examination. Recall start date: January 9, 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 I
Alert / recall typeHealth product recall
Identification numberRA-74922
Background{}
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
AudiencesHealthcare
Source updated2024-01-17

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

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