GE Healthcare Precision 500D Classical R & F system.
Medical device recall Z-2120-2015. Published in FDA’s Enforcement Report on Jul 29, 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 29, 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 2 states named
- 788 (701 US; 87 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?
A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic 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.
788 (701 US; 87 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 # 00000002243MC4 00000017545MC9 00000001018MC1 00000001083MC5 00000003942MC0 00000001707MC9 00000001110MC6 0000000B2055KJ 00000001283MC1 00000002163MC4 00000002189MC9 00000002190MC7 00000000895MC3 00000001165MC0…
Every code shown here, 2,000 characters
Mfg Lot or Serial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…
FDA’s list runs to 10,234 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 Distribution including GU and DC., and to the countries of : Australia, Bulgaria, Canada, Chile, Dominican Republic, Germany, Ireland, Italy, Kuwait, Lebanon, Portugal, Romania, Russia, Saudi Arabia, Slovakia, Spain, Taiwan,Turkey, United Kingdom, Venezuela and Yemen.
The states and territories these words name
- District of Columbia
- Guam
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 20, 2015.
- FDA’s Enforcement Report published it on Jul 29, 2015.
- FDA terminated it on Aug 3, 2017.
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 10,234 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.