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Infinia™ hawkeye™ 4

Official notice

15 Aug 2025

Last checked

15 Aug 2025

Medium riskHealth Canada

An official Health Canada notice concerns Infinia™ hawkeye™ 4. 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 Published 2025-08-15.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77674

Official notice

2025-08-15

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77674

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Affected products

Product 1

Affected products - Hawkeye™ 4, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - H3000WC/WD

Product 2

Affected products - Infinia™ Dual Detector Gamma Camera, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - H3000WT/WE

Product 3

Affected products - Hawkeye™, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - H3000WW

Product 4

Affected products - Hawkeye™, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - H3000YM

Product 5

Affected products - Hawkeye™, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - H3000WZ

Product 6

Affected products - Hawkeye™, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - H3000YS

Product 7

Affected products - Millennium VG Variable Geometry Dual Detector Camera, Lot or serial number - 10332, Model or catalog number - H2505SA

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: GE Medical Israel Functional Imaging, Infinia™ Hawkeye™ 4.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77674

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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