GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems
Medical device recall Z-1966-2015. Published in FDA’s Enforcement Report on Jul 8, 2015.
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 Jul 8, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 3 states named
- 4,053 (3,804 US; 249 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?
The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Legacy and Legacy D Table is intended for use in a diagnostic X-ray system to support patient during general purpose radiological procedures in the horizontal, vertical and Trendelenburg positions.
4,053 (3,804 US; 249 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 # Model, Catalogue or Code # 00000959002WK7 2258627 00000966338WK6 2258627 00000966611WK6 2258627 00000956387WK5 2258627 00000968741WK9 2258627 00000961510WK5 2258627 00000972529WK2 2258627 00000962527WK8 2258627…
Every code shown here, 1,994 characters
Mfg Lot or Serial # Model, Catalogue or Code # 00000959002WK7 2258627 00000966338WK6 2258627 00000966611WK6 2258627 00000956387WK5 2258627 00000968741WK9 2258627 00000961510WK5 2258627 00000972529WK2 2258627 00000962527WK8 2258627 00000963526WK9 2258627 00000955594WK7 2258627 00000956587WK0 2258627 00000959354WK2 2258627 00000964963WK3 2258627 00000955822WK2 2258627 00000969028WK0 2258627 00000970010WK5 2258627 00000977743WK4 2258627 00000977741WK8 2258627 00000961823WK2 2258627 00000966949WK0 2258627 00000974520WK9 2258627 00000969300WK3 2258627 00000980632WK4 2258627 00000968416WK8 2258627 00000954452WK9 2258627 00000976569WK4 2258627 00000966357WK6 2258627 00000965746WK1 2258627 00000973833WK7 2258627 00000968411WK9 2258627 00000981014WK4 2258627 00000978814WK2 2258627 00000983374WK0 2258627 00000969352WK4 2258627 00000956745WK4 2258627 00000959683WK4 2258627 00000960138WK6 2258627 00000978807WK6 2258627 00000966622WK3 2258627 00000972384WK2 2258627 00000986313WK5 2258627 00000978457WK0 2258627 00000980889WK0 2258627 00000962460WK2 2258627 00000968783WK1 2258627 00000975678WK4 2258627 00000963491WK6 2258627 00000961786WK1 2258627 00000973156WK3 2258627 00000953812WK5 2258627 00000967126WK4 2258627 00000969297WK1 2258627 00000978314WK3 2258627 00000975431WK8 2258627 00000978316WK8 2258627 00000963305WK8 2258627 00000973016WK9 2258627 00000954777WK9 2258627 00000966068WK9 2258627 00001005270WK2 2258627 00000959073WK8 2258627 00000972383WK4 2258627 00000956964WK1 2258627 00000972706WK6 2258627 00000971136WK7 2258627 00000964804WK9 2258627 00000964266WK1 2258627 00000977455WK5 2258627 00000968409WK3 2258627 00000976669WK2 2258627 00000967926WK7 2258627 00000957269WK4 2258627 00000964398WK2 2258627 00000963525WK1 2258627 00000954518WK7 2258627 00000973621WK6 2258627 00000977456WK3 2258627 00000963944WK4 2258627 00000962678WK9 2258627 00000960132WK9 2258627 00000963153WK2 2258627 00000976624WK7 2258627 00000977748WK3 2258627 00000967770WK9 2258627 00000961102WK1…
FDA’s list runs to 80,684 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 including PR, GU and DC and the countries of: Afghanistan, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Czech Republic, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Guatemala, Honduras, Indonesia, Ireland, Israel, Italy, Jamaica, Jordan, Korea (Republic of), Kuwait, Libyan Arab Jamahiriya, Malaysia, Malta, Mexico, New Zealand, Panama, Romania, Russia, Saudi Arabia, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen.
The states and territories these words name
- District of Columbia
- Guam
- Puerto Rico
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 Jun 12, 2015.
- FDA classified it on Jul 2, 2015.
- FDA’s Enforcement Report published it on Jul 8, 2015.
- FDA terminated it on Dec 21, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, 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 80,684 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
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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.