GE Healthcare Centricity PACS-IW
Medical device recall Z-1302-2018. Published in FDA’s Enforcement Report on Apr 11, 2018.
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 Apr 11, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 569 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?
A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. 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 indication to the user. While this is rare, this can occur with imaging studies that consist of a very small number of images per series. E.g. CR Thorax exam with 1 image per series.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
569 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Numbers: (a) 2052831-00X: Serial Numbers: 4285-1-Centricity PACS-IW-00558123 4479-1-Centricity PACS-IW-00558214 4291-1-Centricity PACS-IW-00558194 4300-1-Centricity PACS-IW-00558207 100701-1-Centricity PACS-IW-00558322…
Every code shown here, 1,997 characters
Model Numbers: (a) 2052831-00X: Serial Numbers: 4285-1-Centricity PACS-IW-00558123 4479-1-Centricity PACS-IW-00558214 4291-1-Centricity PACS-IW-00558194 4300-1-Centricity PACS-IW-00558207 100701-1-Centricity PACS-IW-00558322 100979-1-Centricity PACS-IW-00558142 4474-1-Centricity PACS-IW-00558169 1153-1-Centricity PACS-IW-00558162 100889-1-Centricity PACS-IW-00558190 100891-1-Centricity PACS-IW-00558184 100892-1-Centricity PACS-IW-00558192 100893-1-Centricity PACS-IW-00558171 100894-1-Centricity PACS-IW-00558200 10994-1-Centricity PACS-IW-00558177 100898-1-Centricity PACS-IW-00558176 100895-1-Centricity PACS-IW-00558195 100823-1-Centricity PACS-IW-00558175 100901-1-Centricity PACS-IW-00558151 100762-1-Centricity PACS-IW-01225872 100902-1-Centricity PACS-IW-00558180 100905-1-Centricity PACS-IW-00558181 100906-1-Centricity PACS-IW-00558165 100908-1-Centricity PACS-IW-00558158 100909-1-Centricity PACS-IW-00558198 100910-1-Centricity PACS-IW-00558178 100911-1-Centricity PACS-IW-00558160 100912-1-Centricity PACS-IW-00558161 100916-1-Centricity PACS-IW-00558199 100917-1-Centricity PACS-IW-00558185 100918-1-Centricity PACS-IW-00558156 4427-1-Centricity PACS-IW-00558113 100919-1-Centricity PACS-IW-00558186 1345-1-Centricity PACS-IW-01225874 100934-1-Centricity PACS-IW-00558201 10683-1-Centricity PACS-IW-00558182 100935-1-Centricity PACS-IW-00558154 100936-1-Centricity PACS-IW-00558153 100938-1-Centricity PACS-IW-00558150 100939-1-Centricity PACS-IW-00558188 100940-1-Centricity PACS-IW-00558173 100943-1-Centricity PACS-IW-00558174 MPX431-Centricity PACS-IW-00044783 RU9038-Centricity PACS-IW-01273313 RU1107-Centricity PACS-IW-01273202 408447-Centricity PACS-IW-00000542 (b) 2049588-008: Serial Numbers: 101039-1-Centricity PACS-IW-00558550 101042-1-Centricity PACS-IW-00558386 100821-1-Centricity PACS-IW-00558325 100674-1-Centricity PACS-IW-00558486 100663-1-Centricity PACS-IW-00558514 101156-1-Centricity PACS-IW-00558446 101181-1-Centricity PACS-IW-00558467 1565-1-Centricity…
FDA’s list runs to 18,976 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 Distribution-US Nationwide
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?
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 Feb 23, 2018.
- FDA classified it on Apr 3, 2018.
- FDA’s Enforcement Report published it on Apr 11, 2018.
- FDA terminated it on Sep 30, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, of Barrington, 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 18,976 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.