GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1)
Medical device recall Z-1078-2014. Published in FDA’s Enforcement Report on Mar 5, 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 Mar 5, 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 42 states named
- 359 (333 US, 26 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 software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option) that may impact patient safety. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the WDR1 are not properly displayed. I
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended for use in all routine radiography exams, and specialized areas including pediatric work, intensive care and trauma, wherever conventional screen-film systems or CR systems may be used. The device is not intended for mammography or fluoroscopy applications.
359 (333 US, 26 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 00000007820HL1 757736WDR1 00000075975HL3 WDR1-RF1 00000075976HL1 530BGDR 00000075977HL9 210MTFP 00000075979HL5 337470WDR2 00000075981HL1 205408WDR1 00000075982HL9 WDR1-RF2 00000075983HL7 337470WDR1…
Every code shown here, 1,988 characters
Mfg Lot or Serial # System ID 00000007820HL1 757736WDR1 00000075975HL3 WDR1-RF1 00000075976HL1 530BGDR 00000075977HL9 210MTFP 00000075979HL5 337470WDR2 00000075981HL1 205408WDR1 00000075982HL9 WDR1-RF2 00000075983HL7 337470WDR1 00000075984HL5 LLPM500D 00000076011HL6 434654RM4 00000076012HL4 585596FPD1 00000076013HL2 520GV500D 00000076014HL0 781624HSSHFP 00000076015HL7 954JDCHWDR1 00000076016HL5 503391SKY 00000076018HL1 954JDCHWDR2 00000076019HL9 518926DRRM4 00000076021HL5 954265WDR1 00000076022HL3 207795CM3WDR 00000076023HL1 719285P500 00000076026HL4 540DALEVILLE 00000076027HL2 410392RAD 00000076028HL0 318495WDR1 00000076285HL6 0002952447 00000076286HL4 918579PROTEUS 00000076287HL2 518926FLRM3 00000076288HL0 ORMCP500DIG 00000076290HL6 713791P500FP4 00000076379HL7 518243WDR1 00000076380HL5 504873FP1 00000076381HL3 435722GDXR 00000076487HL8 989224FLSHPD1 00000076489HL4 229924P500 00000076490HL2 405752RF2 00000076643HL6 COR481360 00000076644HL4 713UTPROTEUS 00000076646HL9 518243WDR1 00000076647HL7 706754EF1 00000076648HL5 COR481360 00000076649HL3 518243WDR1 00000076650HL1 918273CNNP1 00000076651HL9 918434P500 00000076652HL7 714827P500 00000076986HL9 325574WDRRM2 00000076990HL1 878WDR 00000076991HL9 919RALCPFLASH2 00000076995HL0 912384FP5 00000076996HL8 540829RF1DR 00000076997HL6 305LEON27FLGD 00000076998HL4 205877BPRF1 00000077642HL7 989224FLSHPD1 00000077644HL3 240566EDWDR1 00000077647HL6 925370PAD 00000077648HL4 603524500D 00000077649HL2 618443SFP 00000077652HL6 540CULRF2 00000077653HL4 501202WDR14 00000078002HL3 760873FP2 00000078196HL3 318259RM2 00000078201HL1 757736WDR1 00000078669HL9 419538RAD 00000078670HL7 601928PXR 00000078671HL5 512LRMCRF 00000079045HL1 417347P500 00000079046HL9 608364PRFPCL 00000079047HL7 218828WDR1 00000079048HL5 269637FP 00000079049HL3 281274P5DGR 00000079457HL8 501202BNLER 00000079460HL2 507434DR1 00000079461HL0 570455GDXR 00000079662HL3 312CMP500D2 00000079663HL1 330841AND 00000080016HL9 724285WDR 00000080196HL9 325574WDRRM1…
FDA’s list runs to 9,428 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) including the states of AL, AK, AZ, AR, CA, CO, DC, FL. GA, HI. IA, ID, IL, IN, LA, KY, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, TN ,KY, TX, UT, VA, WA, WV, WI and WY., and the countries of ARGENTINA, AUSTRALIA, CANADA, FRANCE, IRELAND, ITALY, JORDAN, ROMANIA, RUSSIA, UNITED ARAB EMIRATES and UNITED KINGDOM.
The states and territories these words name
42 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- District of Columbia
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- 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 Jan 20, 2014.
- FDA classified it on Feb 24, 2014.
- FDA’s Enforcement Report published it on Mar 5, 2014.
- FDA terminated it on Nov 3, 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 9,428 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.