Hearth Record

Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending…

Medical device recall Z-3166-2026. Published in FDA’s Enforcement Report on Sep 23, 2026.

FDA’s own record, on accessdata.fda.gov

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.

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.

Source:

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.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions

1856 systems, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

UDI-DI: V4 - 00840682102766; System IDs: CARTI02312615 CARTI22225617 520784EASFTW1 19233337_EA MARICOPAC02308032 602406SAEAFSW 602997SAEASW-24 SVRHC14765622 520458CVEASW 520780SAEASW 520784EASSASW 520629EA1 BERMUDACA02257222…

Every code shown here, 1,996 characters

UDI-DI: V4 - 00840682102766; System IDs: CARTI02312615 CARTI22225617 520784EASFTW1 19233337_EA MARICOPAC02308032 602406SAEAFSW 602997SAEASW-24 SVRHC14765622 520458CVEASW 520780SAEASW 520784EASSASW 520629EA1 BERMUDACA02257222 BERMUDACA02257223GW ASHPACSEA1P 805395EASW PMHD15081203 805725EASW1 V5SPORTS01804915 559582CAEASW 760775CAEASW 310673CAPACSSW UHVNAEAPRD01 UHEAVNATEST01 UHVNAEAPRD02 UHVNAEAPRD03 UHVNAEAPRD04 UHVNAEAPRD05 UHVNAEAPRD06 310349EASW1 310349EASW2 310349EASW3 310ODCEASW4 ADVENTIST02256061 323726CAEASW NDMGCAWEB PALMDALEM02354935 PALMDALEM19604722 PALMDALEM19604723 661948ISBSW 818676EA01 916781MMBSW1 916781MMBSW2 ADVENTIST1474489 SUTH20087395 707554EASW 916733EASTSW1 916733EASTSW2 916733EASTSW3 916733EASTSW4 916733EASTSW5 916733EASW2 916733EASW3 916733EASW4 916733EASW5 916733SAEASW SUTH20992909 SUTH20992910 SUTH20992912 SUTH20992914 650696EASW 408590EAAIMSW 805542SAEASW VSMY01820424 VCM01983687 SONORAREG26747425 RANCHO02255035 RANCHOTEA01 RANCHODTEA01 UHS24494273 VCM01819620 CWHMC01821420 303584CVEAFSW 303584EASW3 303584EASW1 303715CVEASW GRHD16174555 203384CAEASW 202745CAEASW 302674CCASW 01730933BAYHEALTH JFKR21743924 LAKESIDEM02275735 727462EASW 772468EASW-SAAIM2 EFDVWPTCMAIM04 352333AIMEASW 352331EACCASW 352331EASW BIHT22108325 BHIT11111111111111 ORMC320536538 LARGOMEDI24412138 305223EASW-SAAIM2 DAVIEMEDI20960878 305223EASW-SAAIM3 239860SAEASW 352237CVEASW UCFNONAL20037311AWEA PCMC4-20940705 850494EASW 904819EASW1 904819EASW2 941342EASW HRMT19664009-AIM01 888663AFEASFTW3 VSMAF02345970 BYH02360323EA1 MCC15961440EA NORTHE14610617 BYH14776394AIM1 BHY14776395AIM2 BHY14776396AIM3 BHY14776397AIM4 BYH14929313EA2 BYH14929315EA3 813971ECVPACS 954688EASUV100 NGDC01893571 813873CASAEASW HLEEMOFF21014281 HCAWESTF24284158 BYH26758983CCAEA6 BYH26758991CCAEA7 TRMCN19965352 901392EASW TRMC-21771222 407777EASWT 407777EASW1 407777EASW4 21300644EASW 21301799EASW 21301800EASW 21301807EASW5 706651CVEASW 706596CAEASW 912276EASW 706272CCABSW HMC720996757T 404501EASW1…

FDA’s list runs to 25,483 characters. The first part is shown; the rest is on FDA’s record.

Source:

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.

Source:

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.

Source:

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.
Source:

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.
Source:

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 25,483 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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