Food, drugs, devices › GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Device recall: Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING (Tirat Carmel, N/A) initiated this device recall on 20 Jun 2025; FDA lists 2 product records under event 97193, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING has 7 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, Tirat Carmel, N/A, Israel.
Reason for recall
"Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury."
Distribution
"Worldwide - US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2097-2025 | Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system | 1822 | Class II | Ongoing | 16 Jul 2025 |
| Z-2098-2025 | Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System | 21 | Class II | Ongoing | 16 Jul 2025 |
Context
Other enforcement events for GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 24 Dec 2025 | GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend P | Device | Class II | 1 |
| 10 Dec 2025 | SMV DSX New Line, System, Tomography, Computed, Emission | Device | Class II | 4 |
| 12 Sep 2025 | Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | Device | Class II | 14 |
| 18 Dec 2024 | GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Comp | Device | Class II | 13 |
| 15 Apr 2024 | MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (s | Device | Class II | 1 |
| 19 Dec 2022 | GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) | Device | Class I | 6 |
All 7 events for GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide - US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.