GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems
Medical device recall Z-0911-2014. Published in FDA’s Enforcement Report on Feb 12, 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 Feb 12, 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 2 states named
- 816 (722 US, 94 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 Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor). There is a potential for the locking nut to loosen out of the LCD Video Monitor Suspension yoke. This will not lead to an immediate fall of the suspended monitor since it will
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. 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. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
816 (722 US, 94 OUS)., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
System ID Model, Catalogue or Code # 828213AIRF2 2385123-2 309454FJRM1 2385123-2 217935WF1 2385123-2 434924UVAP1 2385123-2 717627RF2 2385123-2 608287PRE500 2385123-2 304473RF1 2385123-2 717627RF1 2385123-2 801807RM3 2385123-2 904858RM1…
Every code shown here, 1,997 characters
System ID Model, Catalogue or Code # 828213AIRF2 2385123-2 309454FJRM1 2385123-2 217935WF1 2385123-2 434924UVAP1 2385123-2 717627RF2 2385123-2 608287PRE500 2385123-2 304473RF1 2385123-2 717627RF1 2385123-2 801807RM3 2385123-2 904858RM1 2385123-2 325658RF1 2385123-2 828322F6 2385123-2 623327RF1 2385123-2 864573MBR3 2385123-2 913696CRF1 2385123-2 817255NHRM1 2385123-2 217442VXF3A 2385123-2 509332PRF 2385123-2 405752P500 2385123-2 520498RF1 2385123-2 718518RF2 2385123-2 601426PRF1 2385123-2 256MIRF1 2385123-2 231876P500D1 2385123-2 765448DF1 2385123-2 404325EFL1 2385123-2 231935DF2 2385123-2 407321PRF5 2385123-2 903416PD1 2385123-2 970544RM2 2385123-2 314344DR10 2385123-2 423562RF1 2385123-2 608372P500 2385123-2 231876P500D2 2385123-2 765747PRE1 2385123-2 256974P1 2385123-2 972665BPPRE1 2385123-2 423562RF2 2385123-2 937352RM3 2385123-2 972665BPPRE2 2385123-2 314996MBRM2 2385123-2 JAC3D14 2385123-2 410871RF 2385123-2 434924UVAP2 2385123-2 256249CVRF 2385123-2 304526PRE1 2385123-2 843784RF 2385123-2 623327RF2 2385123-2 319235500D 2385123-2 606678RF2 2385123-2 507283P500 2385123-2 802674500D 2385123-2 JAC3E63 2385123-2 972665DDARF 2385123-2 314344DR11 2385123-2 804287RF1 2385123-2 757466RM7 2385123-2 757889RM8 2385123-2 320255F3 2385123-2 865458RF2 2385123-2 337948RF1 2385123-2 601288PRF6 2385123-2 225924RF2 2385123-2 586573P500 2385123-2 940764ROOMD 2385123-2 909793P5R6 2385123-2 602867RM1 2385123-2 740454PRE2 2385123-2 909793P5R4 2385123-2 717657PRE1 2385123-2 706733V8 2385123-2 704735P500D 2385123-2 336719NH135 2385123-2 713359RF3 2385123-2 719546P500 2385123-2 251580RF2 2385123-2 804594RM3 2385123-2 251580RF1 2385123-2 614293PRE4 2385123-2 541396RF1 2385123-2 443481RF4 2385123-2 617726PR64A 2385123-2 215538PRE1 2385123-2 775423RF 2385123-2 765348PR 2385123-2 503215P500D 2385123-2 316689RF500 2385123-2 520TMCRF1 2385123-2 573875CRM2 2385123-2 757886RM2 2385123-2 415600PRC1 2385123-2 414805P500 2385123-2 205387WRF6 2385123-2 352331SPINE 2385123-2 260373RF4 2385123-2…
FDA’s list runs to 17,061 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 Guam and DC but excluding CT, DE, HI and RI; and internationally to: AUSTRALIA, BULGARIA, CANADA, CHILE, DOMINICAN REPUBLIC, GERMANY, HONDURAS, IRELAND, ITALY, KUWAIT, LEBANON, MALTA, NAMIBIA, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SPAIN, SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM, VENEZUELA, and YEMEN.
The states and territories these words name
- District of Columbia
- Guam
They leave out Connecticut, Delaware, Hawaii and Rhode Island.
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 Dec 12, 2013.
- FDA classified it on Feb 3, 2014.
- FDA’s Enforcement Report published it on Feb 12, 2014.
- FDA terminated it on Sep 11, 2014.
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 17,061 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.