Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC)…
Medical device recall Z-3171-2026. Published in FDA’s Enforcement Report on Sep 23, 2026.
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 Sep 23, 2026. 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
- 250 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?
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
250 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
System IDs: CARTI27326018 KGM24849767P2 KGM26790380P1 KGM26790386T1 KGM26790388T2 PIPELINEH26974665 PIPELINEH27036913 KRM25208408 26885371TenantCSH 26897935StgTenCSH VVMC25199249 Not Available VVMC26130320 DDOC26923416 BAYHEALTH26580398…
Every code shown here, 1,995 characters
System IDs: CARTI27326018 KGM24849767P2 KGM26790380P1 KGM26790386T1 KGM26790388T2 PIPELINEH26974665 PIPELINEH27036913 KRM25208408 26885371TenantCSH 26897935StgTenCSH VVMC25199249 Not Available VVMC26130320 DDOC26923416 BAYHEALTH26580398 BAYHEALTH26871765 JFKR27127669 LAKESIDEM27124493 BYH25222926 LMC427127671 KRMC27127670 MH826900861 ICA27062095 NORTHWEST24866978-XE NORTHWEST27294841-XE NORTHWEST27294843-XE JHSJHOCC24849766 ANN & ROBE24866975 JHSJHOCC27005469 GOSH26799709CSHP GOSH26848483CSHT CMAE26304473 CMAE26774289 MSUHEALTH26980323 Not Available CHILDRENS24808132 XE VCP 103829-6-CoreServices Hub-XE VMP 103829-6-CoreServices Hub-XE Test 103829-6-CoreServices Hub-WFC VCP 103829-6-CoreServices Hub-WFC VMP 103829-6-CoreServices Hub-WFC Test OMCR25206023 ETP Prod CoreServices 1 ETP Prod CSH 2 CHILDRENS25171538 26885369TenantCSH BC325168126 BC324829461 BC325239077 BC325239084 BC326538517 NCDC26959094 MINNETOHE26945472 AMIM27062090 VTH26323581 SHOREMEMO24810482 SHOREMEMO24988230 SHOREMEMO25249340 VT27062091 NNAR25264207 107500-1-CoreServices Hub-27003899 UNIVERSITY26715185 MSI25263844 RRA24845093 RICHMONDU26628093 MFCI24810480 MFCI24825168 LMH25269182 TIET24966115 UTMC25263843 USOK26760295 CCA26850726 WYMH26492340 EVCH24849763 106483-1-Tenant CoreServices Hub-27124492 UHS125299932 ANMEDHEA25206013 ANMEDHEA26129703 CH1126596219TPCSHP CNOS26980316 OPP25269183 MHHS24845097 GZMG24848821 26885370TenantCSH 26898047StgTenCSH OVRLK25074987 Prod WFC 2 Prod WFC 1 EVG26454426 EVG26973916 MGH426804058 CSPA27063452 PACSTPSRV Not Available HCIT5559362DB HCIT5529151XEWFC HCIT5529766XEWFC 604520XES 604520XE1 604520TESTXE 604520ZFP--CSH 604520TESTZFP--CSH 604586XE2 HHS25206021 613548TESTUV--XES 613548UV2--XES 613548UV1--XES 905943ZFP--CSH 905943TESTZFP--CSH 905943QAZFP--CSH 705675ZFP-XES to be created to be created Not Available Not Available Not Available Not Available To be created Not Available Not Available HEIDELBERGXXX HEIDELBERGXES Not Available Not Available Not Available…
FDA’s list runs to 3,808 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 Jul 31, 2026.
- FDA classified it on Sep 15, 2026.
- FDA’s Enforcement Report published it on Sep 23, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, of Chicago, IL.
- 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 3,808 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.