Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data,…
Medical device recall Z-3170-2026. 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
- 169 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?
Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions
169 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
System IDs: SevierCou21180109 PMIO26874968 VCM27268845 QTHBL25025522 GRHD20869086A GRHD20869566B GRHD20870043T VVMC22203148 LAKESIDEM22311789 OFMC22161726 OFMCProd24283369 AMCL20962675 LAKESIDEM21200035 NEUROSKEL22629460 FLMC24849713…
Every code shown here, 1,997 characters
System IDs: SevierCou21180109 PMIO26874968 VCM27268845 QTHBL25025522 GRHD20869086A GRHD20869566B GRHD20870043T VVMC22203148 LAKESIDEM22311789 OFMC22161726 OFMCProd24283369 AMCL20962675 LAKESIDEM21200035 NEUROSKEL22629460 FLMC24849713 FLMC23269955 MRMC220924399 MRMC221300628 MRMC221300631T 106684-1-Workflow Core Services-23253822 MRMC221306901 LaitekDataMigrationETPLab1WFC LaitekDataMigrationETPLab2WFC CMCM24346488 QTHDD22236119 QTHDD24934127 24489144TruePACSWFC 25248966TruePACSWFCT 22144965True_PACSWFC HANN21755240 HRHWFC HANN24283725 BC324463044 AMIM27024664 CHERRYCOU20906543 CHERRYCOU21180589T REDI21237465 MDHC26580426 VT25202652 NNAR21175649 104680-1-Workflow Core Services-24492064 NYK20996006 NYK21803243 NYK21803244 UNIVERSITY20575614 26325561TenantWFC NEWYORK26794149 26932125StgTenWFC 26403778TenantWFC RICHMONDU23210868 RICHMONDUWFCTest MFCI25178603 HZC20924408 HZC23291365 106633-1-Workflow Core Services-22208526 CCA20533413 CCA20609478 EVCH22176263 VBHC25014585 27109610TenantWFC 27112412StgTenWFC CMSImagingWFC HRMC21704042 Not Available 106520-1-Workflow Core Services-21291109 OPP25014573 DRISCOLLC26738355 MCHD120544438 MCHD20609496 URSA20991949 GZMG24480191 24819548TenantWFC EVG22631301 25199257TenantWFC Not Available Not Available Not Available Not Available Test TP PROD TP Not Available Not Available Test TP Prod TP Not Available Not Available 672721-Workflow Core Services-24280401 313741-Workflow Core Services-24280410 Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available 24488449 24488458 Not Available Not Available TBD Not Available tbd Not Available Not Available Not Available Not Available Not Available Not Available 106738-1-Workflow Core Services-24437872 HKBH21752373 534530-Workflow Core Services-23217329 SP_FORT_ETP_WFC RAPTAKOS_WFC_1 MMHRC-WFC RSUripSumoharjo_WFC…
FDA’s list runs to 2,653 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 2,653 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.