GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and…
Medical device recall Z-1989-2013. Published in FDA’s Enforcement Report on Aug 28, 2013.
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 Aug 28, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 43 states named
- 445 (421 US, 24 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 recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
445 (421 US, 24 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
FMI# 10879: CRT Monitor Suspension Supporting Hardware Serial # 00000002608GQ8 00000002734GQ2 00000002735GQ9 00000002736GQ7 00000002838GQ1 00000003208GQ6 00000003209GQ4 00000004078GQ2 00000004079GQ0 00000004083GQ2 00000004084GQ0…
Every code shown here, 1,999 characters
FMI# 10879: CRT Monitor Suspension Supporting Hardware Serial # 00000002608GQ8 00000002734GQ2 00000002735GQ9 00000002736GQ7 00000002838GQ1 00000003208GQ6 00000003209GQ4 00000004078GQ2 00000004079GQ0 00000004083GQ2 00000004084GQ0 00000004086GQ5 00000004087GQ3 00000004102GQ0 00000004103GQ8 00000004104GQ6 00000004105GQ3 00000004106GQ1 00000004107GQ9 00000004109GQ5 00000004873GQ6 00000004874GQ4 00000004875GQ1 00000004876GQ9 00000004878GQ5 00000004881GQ9 00000004882GQ7 00000005522GQ8 00000005523GQ6 00000005524GQ4 00000005525GQ1 00000005527GQ7 00000005528GQ5 00000005529GQ3 00000005530GQ1 00000005885GQ9 00000005886GQ7 00000005887GQ5 00000006565GQ6 00000006566GQ4 00000006742GQ1 00000006743GQ9 00000006744GQ7 00000006745GQ4 00000006746GQ2 00000006747GQ0 00000006748GQ8 00000006752GQ0 00000006753GQ8 00000006755GQ3 00000006756GQ1 00000006757GQ9 00000006758GQ7 00000007111GQ8 00000007112GQ6 00000007113GQ4 00000007114GQ2 00000007115GQ9 00000007116GQ7 00000007117GQ5 00000007118GQ3 00000007119GQ1 00000007121GQ7 00000007122GQ5 00000007123GQ3 00000007124GQ1 00000007125GQ8 00000007126GQ6 00000007127GQ4 00000007128GQ2 00000007130GQ8 00000007131GQ6 00000007132GQ4 00000007430GQ2 00000008338GQ6 00000008339GQ4 00000008340GQ2 00000008448GQ3 00000008449GQ1 00000008450GQ9 00000008451GQ7 00000008452GQ5 00000008453GQ3 00000008454GQ1 00000008455GQ8 00000008456GQ6 00000008713GQ0 00000008714GQ8 00000008715GQ5 00000008716GQ3 00000008717GQ1 00000008890GP6 00000008892GP2 00000009027GP4 00000009028GP2 00000009174GP4 00000009392GP2 00000009393GP0 00000009394GP8 00000009395GP5 00000009396GP3 00000009893GQ9 00000009894GQ7 00000009895GQ4 00000009896GQ2 00000009898GQ8 00000009900GQ2 00000009901GQ0 00000009903GQ6 00000009904GQ4 00000009905GQ1 00000009906GQ9 00000009907GQ7 00000009909GQ3 00000009910GQ1 00000009911GQ9 00000009912GQ7 00000010136GQ0 00000010137GQ8 00000010138GQ6 00000010139GQ4 00000010409GP1 00000010411GP7 00000010588GP2 00000010609GP6 00000010610GP4 00000010611GP2 00000010612GP0 00000010613GP8…
FDA’s list runs to 6,738 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 - USA Nationwide in the states of AL, AK, AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, MD, MA, NMI, MN, MS, MO, NE, NV,NH,NJ, NM, NY, NC,ND, OH, OK OR, PA,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY and the countries of CANADA, FRANCE GERMANY, GREAT BRITAIN ITALY, PANAMA, SAUDI ARABIA.
The states and territories these words name
43 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
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 May 2, 2013.
- FDA classified it on Aug 20, 2013.
- FDA’s Enforcement Report published it on Aug 28, 2013.
- FDA terminated it on Nov 26, 2013.
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 6,738 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.