GE Healthcare Precision 500D, Classical R&F System
Medical device recall Z-0010-2015. Published in FDA’s Enforcement Report on Oct 8, 2014.
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 Oct 8, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 40 states named
- 204 (199 US, 5 OUS). 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?
GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations.
204 (199 US, 5 OUS)., 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 00000015997MO7 260347RF 00000149474MO9 423778ENRF1 00000149476MO4 216343R1 00000149477MO2 423778ERF1 00000149478MO0 407296PRE 00000149479MO8 765482WR2 00000149480MO6 478633PDI3 00000149481MO4 404321P500D…
Every code shown here, 1,986 characters
Mfg Lot or Serial # System ID 00000015997MO7 260347RF 00000149474MO9 423778ENRF1 00000149476MO4 216343R1 00000149477MO2 423778ERF1 00000149478MO0 407296PRE 00000149479MO8 765482WR2 00000149480MO6 478633PDI3 00000149481MO4 404321P500D 00000149482MO2 435865500D 00000149483MO0 210297NCRF1 00000149484MO8 334705EA3 00000149485MO5 314577GC64 00000149486MO3 423224RF1 00000149487MO1 847432HP8 00000149488MO9 423778ERF2 00000149489MO7 210616MCTRF 00000149490MO5 773633EP500 00000149491MO3 763520N8 00000149492MO1 773CMHCSRF 00000149493MO9 904202RF 00000149495MO4 208557RM1 00000149496MO2 515226RF 00000149498MO8 847535RF1 00000149499MO6 704210RX5 00000149500MO1 515226RF2 00000149501MO9 970244AMPRF2 00000149502MO7 215750PRECIS1 00000149503MO5 504447P500 00000149505MO0 602344RM7 00000149506MO8 609584RM1 00000149507MO6 603433PRF3 00000149508MO4 828766R2 00000149509MO2 210297SEBRF3 00000149510MO0 651232RF4 00000149511MO8 502868RF1 00000149512MO6 314525SARM2 00000149513MO4 515247RF1 00000150005M00 308398RF 00000152264MO8 708783RM1 00000152265MO5 319283M500D 00000152266MO3 608873RF 00000152267MO1 210297BMCRF11 00000152269MO7 540776RF1 00000152270MO5 409727MJRF1 00000152276MO2 601936RF1 00000152277MO0 409985PRF3 00000152278MO8 617636RMD 00000152279MO6 760FCI2500D 00000152280MO4 973971RF8 00000152281MO2 651480RF1 00000152282MO0 832355SLT3 00000152283MO8 903232LRP500 00000152285MO3 978521MVRF4 00000152286MO1 760830500D 00000152290MO3 304379RF 00000152292M09 260920RF 00000152295MO2 850325RF4 00000152295MO7 850325RF3 00000152296MO0 314577GC31 00000152298M06 320693PREC 00000152302MO6 972698P500D3 00000152307M05 781744RF3 00000152311MO7 972566P500D1 00000152312MO5 720225RM3 00000152313MO3 720225RM1 00000152316MO6 215750PRECIS2 00000152317MO4 270389RF 00000152318MO2 956632MCRF1 00000152321MO6 847570RF10 00000152322MO4 816348BRF1 00000152323MO2 913498MR2 00000152324MO0 662536RF1 00000152325MO7 847872RF1 00000152327MO3 812450RF12 00000152328M01 304792PRE1 00000152329MO9 913541HPR3…
FDA’s list runs to 5,294 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.
Worldwide Distribution - US Nationwide - AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI and in the countries CANADA, GERMANY, UNITED KINGDOM.
The states and territories these words name
40 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Sep 5, 2014.
- FDA classified it on Oct 2, 2014.
- FDA’s Enforcement Report published it on Oct 8, 2014.
- FDA terminated it on Feb 20, 2015.
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 5,294 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.