GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10
Medical device recall Z-1781-2019. Published in FDA’s Enforcement Report on Jun 19, 2019.
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 Jun 19, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 620 units 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?
There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x
620 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a) 2052831-00x, Lot or Serial Numbers: 100839-1-Centricity PACS-IW-00558122 100893-1-Centricity PACS-IW-00558171 4320-1-Centricity PACS-IW-00558202 4474-1-Centricity PACS-IW-00558169 2455-1-Centricity PACS-IW-00558139 100863-1-Centricity…
Every code shown here, 1,987 characters
a) 2052831-00x, Lot or Serial Numbers: 100839-1-Centricity PACS-IW-00558122 100893-1-Centricity PACS-IW-00558171 4320-1-Centricity PACS-IW-00558202 4474-1-Centricity PACS-IW-00558169 2455-1-Centricity PACS-IW-00558139 100863-1-Centricity PACS-IW-00558143 100794-1-Centricity PACS-IW-00558193 4346-1-Centricity PACS-IW-00558136 100909-1-Centricity PACS-IW-00558198 4355-1-Centricity PACS-IW-00558204 100809-1-Centricity PACS-IW-00558124 4300-1-Centricity PACS-IW-00558207 4484-1-Centricity PACS-IW-00558213 4479-1-Centricity PACS-IW-00558214 13240-2-Centricity PACS-IW-01225875 4270-1-Centricity PACS-IW-00558129 11059-2-Centricity PACS-IW-00558101 101598-1-Centricity PACS-IW-00667133 4273-1-Centricity PACS-IW-01225873 4357-1-Centricity PACS-IW-00558444 4293-1-Centricity PACS-IW-00558131 100835-1-Centricity PACS-IW-00558568 100900-1-Centricity PACS-IW-00558170 4344-1-Centricity PACS-IW-00558196 3836-1-Centricity PACS-IW-00558179 4428-1-Centricity PACS-IW-00558205 100609-1-Centricity PACS-IW-00558130 4297-1-Centricity PACS-IW-00558134 100975-1-Centricity PACS-IW-00558137 100667-1-Centricity PACS-IW-00558163 4316-1-Centricity PACS-IW-00558210 4251-1-Centricity PACS-IW-00558120 4254-1-Centricity PACS-IW-00558211 100981-1-Centricity PACS-IW-00558132 100871-1-Centricity PACS-IW-00558146 2553-1-Centricity PACS-IW-00558206 4283-1-Centricity PACS-IW-00558187 4469-1-Centricity PACS-IW-00558128 100020-1-Centricity PACS-IW-00558147 4443-1-Centricity PACS-IW-00558167 4317-1-Centricity PACS-IW-00558208 100775-1-Centricity PACS-IW-00558209 4323-1-Centricity PACS-IW-00558164 100825-1-Centricity PACS-IW-00558172 100830-1-Centricity PACS-IW-00558166 4304-1-Centricity PACS-IW-00558145 4721-1-Centricity PACS-IW-00558138 4104-1-Centricity PACS-IW-00558133 4292-1-Centricity PACS-IW-00558203 100980-1-Centricity PACS-IW-00558140 4343-1-Centricity PACS-IW-00558115 4298-1-Centricity PACS-IW-00558116 4252-1-Centricity PACS-IW-00558119 4287-1-Centricity PACS-IW-00558117 4291-1-Centricity…
FDA’s list runs to 22,146 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
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 May 22, 2019.
- FDA classified it on Jun 13, 2019.
- FDA’s Enforcement Report published it on Jun 19, 2019.
- FDA terminated it on Sep 20, 2024.
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 22,146 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.