Infinia™ Hawkeye™ 4
Last updated
Summary
Product
Infinia™ Hawkeye™ 4
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Hawkeye™ 4 | More than 10 numbers, contact manufacturer. | H3000WC/WD |
| Infinia™ Dual Detector Gamma Camera | More than 10 numbers, contact manufacturer. | H3000WT/WE |
| Hawkeye™ | More than 10 numbers, contact manufacturer. | H3000WW |
| Hawkeye™ | More than 10 numbers, contact manufacturer. | H3000YM |
| Hawkeye™ | More than 10 numbers, contact manufacturer. | H3000WZ |
| Hawkeye™ | More than 10 numbers, contact manufacturer. | H3000YS |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
GE Medical Systems Israel, Functional Imaging
4 Hayozma Street, Tirat Hacarmel, Israel, 0030200
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77674
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