NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended…
Medical device recall Z-1261-2019. 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
- 37 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 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console.
37 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 # 830Y60040 256737NM H3910AC 830X60004 901227NM1 H3910AC 830X60001 479338N830 H3910AC 830Y60036 860496NM830 H3910AC 830X60018 772468NM830 H3910AC 830X60026 954721NM H3910AC 830X60012…
Every code shown here, 1,135 characters
Mfg. Lot or Serial # System ID Model, Catalogue or Code # 830Y60040 256737NM H3910AC 830X60004 901227NM1 H3910AC 830X60001 479338N830 H3910AC 830Y60036 860496NM830 H3910AC 830X60018 772468NM830 H3910AC 830X60026 954721NM H3910AC 830X60012 813315D830 H3910AC 830Y60030 813874D830 H3910AC 830X60011 225761NM1 H3910AC 830X60016 225761NM H3910AC 830Y60029 410554NM H3910AC 830X60019 573458NM H3910AC 830X60027 603742NM830 H3910AC 830X60014 718238D830 H3910AC 830X60015 585396NM H3910AC 830X60006 716862NM830 H3910AC 830Y60031 631726D830 H3910AC 830X60003 585786NM830 H3910AC 830X60021 615316NM830 H3910AC 830Y60034 936CMC830 H3910AC 830X60028 361275NM830 H3910AC 830X60017 956323NM830 H3910AC 830Y60035 304526D830 H3910AC 830X60002 100039NU05 H3910AC 830X60022 705743DNM830 H3910AC 830X60013 M4040557 H3910AC 830Y60032 362759NU01 H3910AC 830Y60033 NS0103 H3910AC 830Y60038 NS0104 H3910AC NT3AG1900002BH NS0204 5376204-32-1 NT3AG1900003BH NS0205 5376204-32-1 NT3AG1900001BH NS0203 5376204-32-1 NT3AG1800001BH NS0201 5376204-32-1 830X60020 NS0101 H3910AC 830X60005 0850260165 H3910AC 830X60008 0850260166 H3910AC 830X60007 752030NU01 H3910AC
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.