GE Proteus XR/A radiographic system
Medical device recall Z-0550-2025. Published in FDA’s Enforcement Report on Dec 4, 2024.
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 Dec 4, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 956 systems 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?
Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Proteus XR/A radiographic system
956 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 00840682120777; System ID: 907443PROTEUS 251847RAD 256737PRO 251435PROT 251275RAD 251275RAD2 256486XR1 256429CR2 334732PXRA 256332RRM1 334418PRO 334418XRA 334670RAD 256487RAD 870898PROT 479BVXR 870541PROT6 870226PROT 870208RF…
Every code shown here, 1,990 characters
UDI-DI: 00840682120777; System ID: 907443PROTEUS 251847RAD 256737PRO 251435PROT 251275RAD 251275RAD2 256486XR1 256429CR2 334732PXRA 256332RRM1 334418PRO 334418XRA 334670RAD 256487RAD 870898PROT 479BVXR 870541PROT6 870226PROT 870208RF 870208XR1 520498PR1 520498PR2 520901GERF1 928348PRO 928348PRO2 520MERPRO RADNETRAD352 310888PRO 818563DR 818461DR 707421NBSDI1 510797RM1 714537RM3 801774ER 909336RAD1 909336RAD2 760379RAD 213744PROTXR1 213744PROTXR2 310825PRO2 925370ORTHO1 925370ORTHO2 AVHRD22776 818360XR1 310374PRO 909788R2 831424RAD2 408885EDB 562493RM1 805418XR1 707429NBGV1 805652DR2 925210RAD1 303FCAUSHXR 970945CARB 720CRHIXR 970565RAD1 303320RAD1 303DHXR1 615812PROT 970945FL4 970BASRAD 970945FL4L 970624XR2 303788SEDXR 303FCLNWBXR 303730RM5 303HIPXR 303450ED 203466PROT 203319PROT 860224PROT 203688PROTLW 203852ED1 561965RAD1 813571ER2 813916XRA 352596PROM 352597RAD1 727FSEDXR1 954HCAERPRKM 850654PRO 305MCHDORAL 904264RAD1 850862PROT 333MHRX 727528RAD1 904230RM1 904399ER1 904399RADWEST 904928RAD 904MMRAD 904OPWESTER 813344PROTXR 321FCR1 305MCHWBRAD 904OPTCCRAD 850469PROT 352333PROTWD 291ERPRO 386774RM1 386774RM2 HCERPRO1 386446RM2 407359OVPRO OVERPRO 386PCHRAD3 561246RAD 727789PROT 850434BER 305MCPCPRO 813763BRPCER1 954476RAD4 954587RM1 386238FHR1 772340XR1 772SLMCER1 904819WGRAD 727341ER 727341PPER1 813282PRO1 813442XRA 863773PROT 404251P1 404686CRAD5 404686MOT2 706396COM 678207PROT1 912466PRO 912466PROT 403150 706257SFP 706335BR1 706335PRO1 229276CR3 678474PROT1 3109851 40401XRGEPRO3 404501P1 912369PROT 912369PROT2 678639PROT 706468XR 229890CR4 770252NR2 770252GBJ3 770434PROT 404251PROT 912754PROT2 706886SR1 770456PRODIG 706678RAD 912287R608 706554MSR1 808873PROA 641424PROT 515832XRA 208785RAD 208359PROT 630315NWMBL1 630946STPROT1 1000001199 312878W8R3 773564WPRO1 630968PRO 630545PROT2 630545PROT3 630545PROT4 847543CLCF 630856PRO1 217732LPR1 630246PROT1 630246PROT2 815300PVPROT 7087471633 7087471635 630545PROT 815439RAD 618282RBRM2 708WSBCPROT1 708783PRO1…
FDA’s list runs to 10,441 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 - US Nationwide distribution.
These words name no state.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Oct 24, 2024.
- FDA classified it on Nov 25, 2024.
- FDA’s Enforcement Report published it on Dec 4, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare (China) Co., Ltd., of Beijing, China.
- 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 10,441 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.