Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system…
Medical device recall Z-1257-2019. 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
- 57 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?
Discovery NM 630 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.
57 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 # 63GY50074 334287NM630 H3101RH 63GX50024 501450D630 H3101RH 630X22925 310657D630 H3100JY 630X22921 951682NMDISC H3100JY 63GY50067 719776DISCNM H3101RH 63GX50001 863494NM H3101RH…
Every code shown here, 1,760 characters
Mfg. Lot or Serial # System ID Model, Catalogue or Code # 63GY50074 334287NM630 H3101RH 63GX50024 501450D630 H3101RH 630X22925 310657D630 H3100JY 630X22921 951682NMDISC H3100JY 63GY50067 719776DISCNM H3101RH 63GX50001 863494NM H3101RH 630X22923 904296NM H3100JY 63GX50037 305223D630A H3101RH 63GX50060 305223D630B H3101RH 63GX50034 478289DIS H3101RH 63GX50014 618998NM H3101RH 63GX50019 270745NM1 H3101RH 63GY50078 269966NMDISC H3101RH 63GX50021 906225CARDNM2 H3101RH 63GX50022 906225CARDNM1 H3101RH 63GX50018 269637NM630 H3101RH 63GX50009 NM555658 H3101RH 63GY50080 4695517NM11 H3101RH 63GY50077 919954NMDISC H3101RH 63GX50043 828286RHD630 H3101RH 63GX50020 402481D630C H3101RH 63GX50040 973450CARD630 H3101RH 63GX50054 973450D630 H3101RH 63GX50008 856641NM H3101RH 63GY50079 SHIPPED (GON 4722927) H3101RH 63GX50061 702962NM1 H3101RH 63GX50035 702962NM2 5376204-31 63GX50050 702388DISC H3101RH 63GX50062 702724DISCNM H3101RH 63GX50032 513861NM H3101RH 63GX50055 513861NM1 H3101RH 63GX50013 740MGD630 H3101RH 63GX50047 440743D630 H3101RH 63GX50002 419251NM H3101RH 63GX50025 330841DISCNM H3101RH 63GX50033 330841DISCNM2 H3101RH 63GX50038 918756D630 H3101RH 63GX50044 803865D630 H3101RH 63GY50068 854529NMDISC H3101RH 63GY50069 901516NM 5376204-31 63GX50016 615873NM H3101RH 63GY50075 SHIPPED (GON 4561460) H3101RH 63GX50012 832505D630 H3101RH 63GX50005 713440NM630B H3101RH 63GX50029 281MHNE630 H3101RH 630X22919 972258NM630 H3100JY 63GX50046 210351NM H3101RH 63GX50049 281MWL630B H3101RH 63GX50039 281MWL630A H3101RH 63GX50030 434243DIS H3101RH 63GX50011 LGMONT630 H3101RH 63GX50017 540316NM630 5791570 630X22922 804764D630C H3100JY 630X22924 UESS01NU03 H3100JY 63GX50048 418404NU02 H3101RH 63GX50041 083026202460918 H3101RH NT2PG1800001BH NT8003 5376204-31-1
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.