Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine…
Medical device recall Z-1266-2019. Published in FDA’s Enforcement Report on May 8, 2019.
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 May 8, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 35 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?
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies.
35 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg. Lot or Serial # System ID Model, Catalogue or Code # ONMX26520 714456OPT1 5474055 ONMX26518 408559O640 H3100JZ ONMX26529 408559O640 H3100JZ ONMX26528 970298NM 5474055 ONMX26537 303425O640 5474055 ONMX26538 303689O640 5474055 ONMX26539…
Every code shown here, 1,113 characters
Mfg. Lot or Serial # System ID Model, Catalogue or Code # ONMX26520 714456OPT1 5474055 ONMX26518 408559O640 H3100JZ ONMX26529 408559O640 H3100JZ ONMX26528 970298NM 5474055 ONMX26537 303425O640 5474055 ONMX26538 303689O640 5474055 ONMX26539 970298NM1 5474055 ONMX26519 860358O640 H3100JZ ONMX26530 302430NUC640 H3100JZ ONMX26512 515699NM1 H3100JZ ONMX26503 630933NM6402 H3100JZ ONMX26513 316962NM640 H3100JZ ONMX26511 443777NM 5474055 ONMX26542 301315NMOPTIMA H3100JZ ONMX26510 906225NMCT H3100JZ ONMX26514 4695537NM11 H3100JZ ONMX26507 RMCOPTIMA H3100JZ ONMX26515 701239NM640B 5474055 ONMX26534 402473OPT640 H3100JZ 64GX51001 SHIPPED (GON 4562299) H3101RL 64GY51006 SHIPPED (AO 1635868) H3101RL 64GY51007 SHIPPED (GON 4562663) H3101RL ONMX26544 740593OPT640 H3100JZ ONMX26531 614MCMN640 5474055 ONMX26517 513870NM640 H3100JZ ONMX26524 614GCNM6402 5474055 ONMX26527 614GCNM640 H3100JZ ONMX26546 605347NM640 H3100JZ ONMX26516 469993NM H3100JZ ONMX26476 608263OPT640 H3100JZ ONMX26480 403529D640 H3100JZ ONMX26502 4534444NM12 H3100JZ ONMX26536 HR4052NM03 H3100JZ ONMX26521 NTE042 H3100JZ ONMX26525 ZA2719CT01 H3100JZ
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.
US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Mar 20, 2019.
- FDA classified it on May 2, 2019.
- FDA’s Enforcement Report published it on May 8, 2019.
- FDA terminated it on Oct 5, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- 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.”
- 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.