GE Healthcare Infinia II Hawkeye 4
Medical device recall Z-0899-2025. Published in FDA’s Enforcement Report on Jan 22, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 22, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 845 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; System, Tomography, Computed, Emission
845 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1) H2799PP: UDI/DI N/A, System ID 850260060, Serial Number 16130. 2) H2799PR: UDI/DI N/A, System ID 217347INF2, Serial Number 17325. 3) H2799YC: UDI/DI N/A, System ID M54606103, Serial Number 16846. 4) H2799YD: UDI/DI N/A, System ID…
Every code shown here, 1,997 characters
1) H2799PP: UDI/DI N/A, System ID 850260060, Serial Number 16130. 2) H2799PR: UDI/DI N/A, System ID 217347INF2, Serial Number 17325. 3) H2799YC: UDI/DI N/A, System ID M54606103, Serial Number 16846. 4) H2799YD: UDI/DI N/A, System ID M348992912, Serial Number 17033. 5) H3000WC: UDI/DI N/A, System ID 907562HK4, Serial Number 18610; UDI/DI N/A, System ID 907562HK4, Serial Number 18643; UDI/DI N/A, System ID 205783INF1, Serial Number 17571; UDI/DI N/A, System ID 479553INF, Serial Number 18470; UDI/DI N/A, System ID 479441INF1, Serial Number 17301; UDI/DI N/A, System ID 928855INF, Serial Number 17190; UDI/DI N/A, System ID 480512INF1, Serial Number 17019; UDI/DI N/A, System ID 602406INF1, Serial Number 18422; UDI/DI N/A, System ID 602406INF3, Serial Number 18465; UDI/DI N/A, System ID 480323INFRM3, Serial Number 17488; UDI/DI N/A, System ID 480882INF1, Serial Number 18026; UDI/DI N/A, System ID 530888IN1, Serial Number 18579; UDI/DI N/A, System ID 760873NUC, Serial Number 17290; UDI/DI N/A, System ID 6502IN1, Serial Number 17680; UDI/DI N/A, System ID 916537IN2, Serial Number 17264; UDI/DI N/A, System ID 510537IN1, Serial Number 18280; UDI/DI N/A, System ID 626915INF1, Serial Number 16946; UDI/DI N/A, System ID 209223IN, Serial Number 18308; UDI/DI N/A, System ID 559353IN, Serial Number 17995; UDI/DI N/A, System ID 626573INF1, Serial Number 17410; UDI/DI N/A, System ID 510400IN, Serial Number 17108; UDI/DI N/A, System ID 530533IN, Serial Number 18531; UDI/DI N/A, System ID 916782IN1, Serial Number 17973; UDI/DI N/A, System ID 916782IN2, Serial Number 17987; UDI/DI N/A, System ID 916453IN, Serial Number 17373; UDI/DI N/A, System ID 916703IN2, Serial Number 17699; UDI/DI N/A, System ID 916733IN, Serial Number 18460; UDI/DI N/A, System ID 415838IN, Serial Number 17269; UDI/DI N/A, System ID 415353IN2, Serial Number 18305; UDI/DI N/A, System ID 4082IN, Serial Number 17392; UDI/DI N/A, System ID 408315IN, Serial Number 17579; UDI/DI N/A, System ID 408259IN2, Serial Number…
FDA’s list runs to 46,735 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 18, 2024.
- FDA classified it on Jan 10, 2025.
- FDA’s Enforcement Report published it on Jan 22, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, of Tirat Carmel, Israel.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 46,735 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.