Discovery NM 630
Medical device recall Z-2994-2020. Published in FDA’s Enforcement Report on Sep 30, 2020.
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 Sep 30, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 27 states named in where it went
- 62 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?
Rotor bearing screws were found loose on detector.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Discovery NM 630 Model # H3101RH
62 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial # 63GX50024 System ID: 501450D630 Serial # 63GX50001 System ID: 863494NM Serial # 63GX50037 System ID: 3v05223D630A Serial # 63GX50060 System ID: 305223D630B Serial # 63GX50017 Not Available Serial # 63GX50034 System ID: 478289DIS…
Every code shown here, 1,999 characters
Serial # 63GX50024 System ID: 501450D630 Serial # 63GX50001 System ID: 863494NM Serial # 63GX50037 System ID: 3v05223D630A Serial # 63GX50060 System ID: 305223D630B Serial # 63GX50017 Not Available Serial # 63GX50034 System ID: 478289DIS Serial # 63GX50040 System ID: 0004624609 Serial # 63GX50014 System ID: 618998NM Serial # 63GX50019 System ID: 270745NM1 Serial # 63GX50016 System ID: Not Available Serial # 63GX50022 System ID: 906225CARDNM1 Serial # 63GX50021 System ID: 906225CARDNM2 Serial # 63GX50018 System ID: 269637NM630 Serial # 63GX50009 System ID: NM555658 Serial # 63GX50031 System ID: Not Available Serial # 63GX50020 System ID: 402481D630C Serial # 63GX50054 System ID: 973450D630 Serial # 63GX50008 System ID: 856641NM Serial # 63GX50061 System ID: 702962NM1 Serial # 63GX50062 System ID: 702724NM1 Serial # 63GX50050 System ID: 702388DISC Serial # 63GX50043 Not Available Serial # 63GX50032 System ID: 513861NM Serial # 63GX50055 System ID: 513861NM1 Serial # 63GX50013 System ID: 740MGD630 Serial # 63GX50047 System ID: 440743D630 Serial # 63GX50002 System ID: 419251NM Serial # 63GX50025 System ID: 330841DISCNM Serial # 63GX50033 System ID: 330841DISCNM2 Serial # 63GX50038 System ID: 918756D630 Serial # 63GX50044 System ID: 803865D630 Serial # 63GX50035 Not Available Serial # 63GX50005 System ID: 713440NM630B Serial # 63GX50029 System ID: 281MHNE630 Serial # 63GX50012 System ID: 832505D630 Serial # 63GX50046 System ID: 210351NM Serial # 63GX50039 System ID: 281MWL630A Serial # 63GX50049 System ID: 281MWL630B Serial # 63GX50011 System ID: LGMONT630 Serial # 63GX50030 System ID: 434243DIS Serial # 63GX50052 System ID: NM5892AR Serial # 63GX50051 System ID: NM2009AR Serial # 63GX50015 System ID: NM63GX50015 Serial # 63GX50027 System ID: NM63GX50027 Serial # 63GX50036 System ID: NM63GX50036 Serial # 63GX50006 System ID: NM63GX50006 Serial # 63GX50007 System ID: NM63GX50007 Serial # 63GX50010 System ID: NM63GX50010 Serial # 63GX50026 System ID: NM63GX50026XE Serial…
FDA’s list runs to 2,548 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.
USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM
The states and territories these words name
27 states and territories.
Every one of them
- Arkansas
- Connecticut
- Florida
- Georgia
- Illinois
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Nebraska
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Virginia
- Vermont
- Washington
- Wisconsin
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?
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 Aug 14, 2020.
- FDA classified it on Sep 21, 2020.
- FDA’s Enforcement Report published it on Sep 30, 2020.
- FDA terminated it on May 6, 2021.
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.”
- FDA’s list of codes runs to 2,548 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
-
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.