GE Healthcare Brivo NM 615
Medical device recall Z-0889-2025. 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
- 116 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 Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission
116 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1) 5376204-15: UDI/DI 00840682145503, System ID 502629NMGD, Serial Number NT2UG2100002BH; UDI/DI 00840682117869, System ID 509455BRIVO, Serial Number NT24G1700010BH, UDI/DI N/A, System ID 248544D630, Serial Number…
Every code shown here, 1,999 characters
1) 5376204-15: UDI/DI 00840682145503, System ID 502629NMGD, Serial Number NT2UG2100002BH; UDI/DI 00840682117869, System ID 509455BRIVO, Serial Number NT24G1700010BH, UDI/DI N/A, System ID 248544D630, Serial Number NT2QG1900003BH\NT2UG2100001BH. 2) H2401MA: UDI/DI Not Available, System ID 501552D615, Serial Number NT24G1600023; UDI/DI Not Available, System ID 100035454149, Serial Number T2CG15015/100035454149; UDI/DI Not Available, System ID 337643NM, Serial Number NT24G1600021; UDI/DI Not Available, System ID 718963B615, Serial Number NT24G1700009; UDI/DI Not Available, System ID Not Available, Serial Number NT24G1600020; UDI/DI Not Available, System ID 509455BRIVO, Serial Number NT24G1700010; UDI/DI Not Available, System ID 509455BRIVO, Serial Number NT24G1800001; UDI/DI (01)00840682117869(11)17060021NT24G1700003BH, System ID NM6583AR, Serial Number NT24G1700003; UDI/DI (01)00840682117869(11)17090021NT24G1700006BH, System ID NT24G1700006BH, Serial Number NT24G1700006; UDI/DI (01)00840682117869(11)17080021NT24G1700004BH, System ID NT24G1700004BH, Serial Number NT24G1700004; UDI/DI Not Available, System ID Not Available, Serial Number NT24G1700008; UDI/DI Not Available, System ID CS1052NM10, Serial Number T2CG15010/166BH9; UDI/DI Not Available, System ID DK1043NM01, Serial Number T2CG15009/163BH6; UDI/DI Not Available, System ID EG2559NM01, Serial Number NT24G1700001; UDI/DI Not Available, System ID M4143529, Serial Number T2CG16018/187BH5; UDI/DI Not Available, System ID 083026108252217, Serial Number T2CG16019/232BH9; UDI/DI Not Available, System ID 083026108252217, Serial Number NT24G1700005; UDI/DI Not Available, System ID 083026861420919, Serial Number NT24G1800007; UDI/DI Not Available, System ID Not Available, Serial Number T2CG13006/127BH1; UDI/DI Not Available, System ID 083026862894721, Serial Number NT24G1800005; UDI/DI Not Available, System ID 083026861823315, Serial Number T2CG15014/177BH6; UDI/DI Not Available, System ID 083026208602217, Serial Number…
FDA’s list runs to 7,298 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 7,298 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.