NM/CT 850 Model Number: H3907AD
Medical device recall Z-2991-2020. 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/CT 850 Model Number: H3907AD
25 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial # 85EX67001 System ID: 203789NM850 Serial # 85EX67023 System ID: 813443D850 Serial # 850X61005 System ID: 847618NM850 Serial # 85EX67019 System ID: 773296NM850 Serial # 85EX67021 System ID: 217554NMCT Serial # 85EX67008 System ID:…
Every code shown here, 1,018 characters
Serial # 85EX67001 System ID: 203789NM850 Serial # 85EX67023 System ID: 813443D850 Serial # 850X61005 System ID: 847618NM850 Serial # 85EX67019 System ID: 773296NM850 Serial # 85EX67021 System ID: 217554NMCT Serial # 85EX67008 System ID: 779696NM850 Serial # 85EY67015 System ID: 504988NM850 Serial # 85EX67017 System ID: 318212NM Serial # 85EX67012 System ID: 781729NM Serial # 85EX67006 System ID: 573814NM2 Serial # 850X61001 System ID: Not Available Serial # 85EX67002 System ID: 419289D850 Serial # 85EX67009 System ID: 513732NM Serial # 85EX67016 System ID: 972969NM Serial # 85EX67004 System ID: 571472NM850 Serial # 85EX67010 System ID: 804289NM850A Serial # 85EX67011 System ID: 804281NM850A Serial # 85EX67005 System ID: 715717NMCT Serial # 85EX67018 System ID: 414219NMCT Serial # 85EX67013 System ID: 920456NM Serial # 850X61004 System ID: 030601NU06 Serial # 85EX67007 System ID: A5116074 Serial # 850X61002 System ID: NS0001 Serial # 85EX67003 System ID: PL1692NM05 Serial # 85EX67014 System ID: PPR59076
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.