GE Healthcare Infinia II
Medical device recall Z-0897-2025. 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
- 877 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, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
877 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1) H2799ZP: UDI/DI N/A, System ID A5109665, Serial Number 16611; 2) H3000WT: UDI/DI N/A, System ID 205408NUC, Serial Number 17419; UDI/DI N/A, System ID 256341NRM1, Serial Number 18226; UDI/DI N/A, System ID 256494NM1, Serial Number 17133;…
Every code shown here, 1,999 characters
1) H2799ZP: UDI/DI N/A, System ID A5109665, Serial Number 16611; 2) H3000WT: UDI/DI N/A, System ID 205408NUC, Serial Number 17419; UDI/DI N/A, System ID 256341NRM1, Serial Number 18226; UDI/DI N/A, System ID 256494NM1, Serial Number 17133; UDI/DI N/A, System ID 256543INF1, Serial Number 17182; UDI/DI N/A, System ID 205408INF2, Serial Number 18157; UDI/DI N/A, System ID 256429INF1, Serial Number 17557; UDI/DI N/A, System ID 256327NUC, Serial Number 17900; UDI/DI N/A, System ID 334418INF, Serial Number 17266; UDI/DI N/A, System ID 256386HKNM2, Serial Number 16970; UDI/DI N/A, System ID 205750INF, Serial Number 16802; UDI/DI N/A, System ID 501776INF, Serial Number 17294; UDI/DI N/A, System ID 479463INF2, Serial Number 16900; UDI/DI N/A, System ID 501202INF, Serial Number 16564; UDI/DI N/A, System ID 479967INF, Serial Number 16817; UDI/DI N/A, System ID 479549INF, Serial Number 18319; UDI/DI N/A, System ID 479751INF, Serial Number 16800; UDI/DI N/A, System ID 928214INF, Serial Number 17075; UDI/DI N/A, System ID 520868INF, Serial Number 18289; UDI/DI N/A, System ID 602588INF, Serial Number 17054; UDI/DI N/A, System ID 623406INF1, Serial Number 17064; UDI/DI N/A, System ID 480512INF2, Serial Number 18250; UDI/DI N/A, System ID 623478NM2, Serial Number 16223; UDI/DI N/A, System ID 602406INF, Serial Number 17739; UDI/DI N/A, System ID 602406OPINF, Serial Number 17746; UDI/DI N/A, System ID 480324INF, Serial Number 17150; UDI/DI N/A, System ID 480323INFRM2, Serial Number 17584; UDI/DI N/A, System ID 480882INF2, Serial Number 17998; UDI/DI N/A, System ID 441236INFINIA, Serial Number 16912; UDI/DI N/A, System ID 925779IN, Serial Number 17618; UDI/DI N/A, System ID 805489INF1, Serial Number 17043; UDI/DI N/A, System ID 6502IN2, Serial Number 17962; UDI/DI N/A, System ID 760452INF1, Serial Number 18399; UDI/DI N/A, System ID 415925INF, Serial Number 16863; UDI/DI N/A, System ID 661949NUC1, Serial Number 17730; UDI/DI N/A, System ID 805737INF1, Serial Number 17772; UDI/DI N/A,…
FDA’s list runs to 48,152 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 48,152 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
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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.