NM 830 Model # H3910AC
Medical device recall Z-2995-2020. 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
- 25 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?
NM 830 Model # H3910AC
25 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial # 830X60001 System ID: 479338N830 Serial # 830X60004 System ID: 901227NM1 Serial # 830X60018 System ID: 772468NM830 Serial # 830X60012 System ID: 813315D830 Serial # 830X60011 System ID: 225761NM1 Serial # 830X60014 System ID:…
Every code shown here, 1,013 characters
Serial # 830X60001 System ID: 479338N830 Serial # 830X60004 System ID: 901227NM1 Serial # 830X60018 System ID: 772468NM830 Serial # 830X60012 System ID: 813315D830 Serial # 830X60011 System ID: 225761NM1 Serial # 830X60014 System ID: 225761NM Serial # 830X60016 System ID: 225761NM Serial # 830X60019 System ID: 573458NM Serial # 830X60023 System ID: 718238D830 Serial # 830X60006 System ID: 716862NM830 Serial # 830X60015 System ID: 585396NM Serial # 830X60003 System ID: 585786NM830 Serial # 830X60025 System ID: 405717NM830 Serial # 830X60021 System ID: 615316NM830 Serial # 830X60017 System ID: 956323NM830 Serial # 830X60002 System ID: 100039NU05 Serial # 830X60022 System ID: 705743DNM830 Serial # 830X60024 System ID: 416898NM830 Serial # 830X60013 System ID: M4040557 Serial # 830X60010 System ID: NS0102 Serial # 830X60020 System ID: NS0101 Serial # 830X60009 System ID: 0850260168 Serial # 830X60005 System ID: 0850260165 Serial # 830X60008 System ID: 0850260166 Serial # 830X60007 System ID: 752030NU01
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.”
- 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.