NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures…
Medical device recall Z-1262-2019. 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
- 31 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?
NM/CT 850 Product Usage: The GE NM/CT 850 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 system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography component which is intended specifically for enabling attenuation correction and anatomical localization of SPECT images.
31 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 # 85EX67018 4740081NM11 H3907AD 85EX67001 203789NM850 H3907AD 850X61005 319768NMCT H3907AD 850Y61006 319768NMH988 H3907AD 85EX67022 847618NM H3907AD 85EX67019 773975NMCT H3907AD…
Every code shown here, 1,038 characters
Mfg. Lot or Serial # System ID Model, Catalogue or Code # 85EX67018 4740081NM11 H3907AD 85EX67001 203789NM850 H3907AD 850X61005 319768NMCT H3907AD 850Y61006 319768NMH988 H3907AD 85EX67022 847618NM H3907AD 85EX67019 773975NMCT H3907AD 85EX67008 779696NM850 H3907AD 85EX67017 318212NM H3907AD 85EX67012 781729NM H3907AD 85EX67015 SHIPPED (AO 1623723) H3907AD 85EX67020 SHIPPED (GON 4745963) H3907AD 85EX67023 SHIPPED (GON 4704278) H3907AD 85EX67024 SHIPPED (GON 4710759) H3907AD 85EY67025 SHIPPED (AO 1638499) H3907AD 85EY67026 SHIPPED (AO 1638498) H3907AD 85EY67028 SHIPPED (AO 1638502) H3907AD 85EX67009 513732NM 5782013 85EX67002 419289D850 H3907AD 85EX67016 972969NM H3907AD 85EX67004 571472NM850 H3907AD 85EX67021 SHIPPED (GON 4640067) H3907AD 85EX67010 804289NM850A H3907AD 85EX67011 804281NM850A H3907AD 85EX67005 715717NMCT H3907AD 85EX67013 920456NM H3907AD 850X61004 030601NU06 H3907AD 850X61002 NS0001 H3907AD NT3BG1900001BH NS0401 5376204-50-1 85EX67003 PL1692NM05 H3907AD 85EX67014 PPR59076 H3907AD 850Y61007 SK1082NM02 H3907AD
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.