Public recall detail

Infinia™ Hawkeye™ 4

2025-07-04

medium
Recall Safety notice
Quick summary

Quick summary: Infinia™ Hawkeye™ 4. Date: 2025-07-04.

Recommended action

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

Recall details

Quick summary: Infinia™ Hawkeye™ 4. Date: 2025-07-04.

Official details

Affected product details

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

BrandGe Medical Systems Israel, Functional Imaging
ProductInfinia™ Hawkeye™ 4
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77674

Affected products

ProductHawkeye™ 4
LotMore than 10 numbers, contact manufacturer.
ModelH3000WC/WD
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHawkeye™ 4
ProductInfinia™ Dual Detector Gamma Camera
LotMore than 10 numbers, contact manufacturer.
ModelH3000WT/WE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionInfinia™ Dual Detector Gamma Camera
ProductHawkeye™
LotMore than 10 numbers, contact manufacturer.
ModelH3000WW
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHawkeye™
ProductHawkeye™
LotMore than 10 numbers, contact manufacturer.
ModelH3000YM
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHawkeye™
ProductHawkeye™
LotMore than 10 numbers, contact manufacturer.
ModelH3000WZ
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHawkeye™
ProductHawkeye™
LotMore than 10 numbers, contact manufacturer.
ModelH3000YS
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHawkeye™
ProductMillennium VG Variable Geometry Dual Detector Camera
Lot10332
ModelH2505SA
Serial number10332
DescriptionMillennium VG Variable Geometry Dual Detector Camera

Issue

GE Healthcare has become aware of a potential safety issue related to possible unintended radial detector motion, which can occur during patient setup or during a patient scan. Recall start date: June 25, 2025

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesGE Medical Systems Israel, Functional Imaging 4 Hayozma Street, Tirat Hacarmel, Israel, 0030200
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77674
Background{}
CompaniesGE Medical Systems Israel, Functional Imaging 4 Hayozma Street, Tirat Hacarmel, Israel, 0030200
AudiencesHealthcare
Source updated2025-08-15

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

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