GE Healthcare Optima NM/CT 640
Medical device recall Z-0896-2025. 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
- 430 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 Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
430 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1) H3100JZ: UDI/DI N/A, System ID UAB640, Serial Number 26139/25146; UDI/DI N/A, System ID 479441N640, Serial Number 26150/25152; UDI/DI N/A, System ID 480BAY640, Serial Number 26195/25195; UDI/DI N/A, System ID 602UACC640, Serial Number…
Every code shown here, 2,000 characters
1) H3100JZ: UDI/DI N/A, System ID UAB640, Serial Number 26139/25146; UDI/DI N/A, System ID 479441N640, Serial Number 26150/25152; UDI/DI N/A, System ID 480BAY640, Serial Number 26195/25195; UDI/DI N/A, System ID 602UACC640, Serial Number 26191/25189; UDI/DI N/A, System ID 520VA640, Serial Number 26329/640V25328; UDI/DI N/A, System ID 530756OPT1, Serial Number ONMW26439/640W25433; UDI/DI N/A, System ID 626359D640, Serial Number 26109/25111; UDI/DI N/A, System ID 858824NM640, Serial Number 26221/25222; UDI/DI N/A, System ID 909558NM640, Serial Number 26297/640V25296; UDI/DI N/A, System ID 949364D640, Serial Number ONMW26437/640W25432; UDI/DI N/A, System ID 510437O640, Serial Number 26199/25203; UDI/DI N/A, System ID 714456OPT1, Serial Number ONMX26520/640X25513; UDI/DI N/A, System ID 916973OPT1, Serial Number ONMW26426/640W25422; UDI/DI N/A, System ID 619543NM640, Serial Number 26281/25276; UDI/DI N/A, System ID 415300OPTIMA, Serial Number ONMX26481/640X25475; UDI/DI N/A, System ID 415353D640, Serial Number 26149/25115; UDI/DI N/A, System ID 415221NM640 , Serial Number ONMY26475/640Y25556; UDI/DI N/A, System ID 408559O640, Serial Number ONMX26529/640X25522; UDI/DI N/A, System ID 650742OPTIMA, Serial Number ONMX26518/640X25509; UDI/DI N/A, System ID 209476OPT1, Serial Number 26338/640V25337; UDI/DI N/A, System ID 310222NM640, Serial Number ONMW26418/640W25413; UDI/DI N/A, System ID 707554OPT1, Serial Number 26140/25145; UDI/DI N/A, System ID 303695NM1, Serial Number ONMW26436/640W25431; UDI/DI N/A, System ID 303498NMOPTIMA, Serial Number ONMX26505/640X25500; UDI/DI N/A, System ID 970298NM2, Serial Number ONMX26539/640X25535; UDI/DI N/A, System ID 970298NM1, Serial Number ONMX26528/640X25521; UDI/DI N/A, System ID 303689O640, Serial Number ONMX26538/640X25533; UDI/DI N/A, System ID 303PAHO640B, Serial Number ONMW26415/640W25414; UDI/DI N/A, System ID 303PAHO640, Serial Number 26318/640V25317; UDI/DI N/A, System ID 203576NM640, Serial Number 26336/640V25335; UDI/DI N/A,…
FDA’s list runs to 27,860 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 27,860 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.