GE Healthcare Centricity Cardiology CA1000 (CA1000)
Medical device recall Z-1486-2025. Published in FDA’s Enforcement Report on Apr 9, 2025.
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 9, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 633 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 security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.
633 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model/Catalog/Code # 2033901-001, Installed Product ID 14335625-Centricity CA1000-19675863, UDI UDI Not Required, System ID HCIT4082079CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 11558-1-Centricity CA1000-00099550, UDI…
Every code shown here, 1,993 characters
Model/Catalog/Code # 2033901-001, Installed Product ID 14335625-Centricity CA1000-19675863, UDI UDI Not Required, System ID HCIT4082079CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 11558-1-Centricity CA1000-00099550, UDI UDI Not Required, System ID 520855CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103987-1-Centricity CA1000-00102841, UDI UDI Not Required, System ID 928537CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 9990-1-Centricity CA1000-00101135, UDI UDI not required, System ID 661327CWS01; Model/Catalog/Code # 2038437-001, Installed Product ID 10318-1-Centricity CA1000-00105877, UDI UDI not required, System ID 818397CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10994-1-Centricity CA1000-00102387, UDI UDI Not required, System ID 909464CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 102131-1-Centricity CA1000-00105886, UDI UDI not required, System ID 818409CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4161-1-Centricity CA1000-00105894, UDI UDI Not Required, System ID 818502CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103743-1-Centricity CA1000-00099665, UDI UDI Not Required, System ID 559582CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4408-2-Centricity CA1000-00101725, UDI UDI not required, System ID 714843CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 4532-4-Centricity CA1000-00107356, UDI UDI Not Required, System ID 310673CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4009-2-Centricity CA1000-00100791, UDI UDI not required, System ID 619260CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1354-8-Centricity CA1000-00102389, UDI UDI not required, System ID 909558CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 9927-2-Centricity CA1000-00099762, UDI UDI not required, System ID 562491CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11299-9-Centricity…
FDA’s list runs to 93,855 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.
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?
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 Feb 19, 2025.
- FDA classified it on Mar 28, 2025.
- FDA’s Enforcement Report published it on Apr 9, 2025.
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 93,855 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.