FDA Medical devices recall ·
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model recall
- Recall number
- Z-0039-2025
- Date
- (initiated August 29, 2024)
- Company / brand
- GE Healthcare
500 W Monroe St, Chicago, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1500 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ 2089507-131; d)¿¿¿¿ 2089507-135; e)¿¿¿¿ 2089507-136; f)¿¿¿¿¿¿ 2089507-140; g)¿¿¿¿¿ 2089507-144; h)¿¿¿¿ 2089507-145; i)¿¿¿¿¿¿ 2089507-149; j)¿¿¿¿¿¿ 2089507-153; k)¿¿¿¿¿ 2089507-154; l)¿¿¿¿¿¿ 2089507-155; m)¿¿¿ 2089507-156; n)¿¿¿¿ 2089507-157; o)¿¿¿¿ K2037DAED; p)¿¿¿¿ K2037DBED; q)¿¿¿¿ K2037DED; r)¿¿¿¿¿ K2037DJED; s)¿¿¿¿¿ K2037DNED; t)¿¿¿¿¿ K2042TTED; u)¿¿¿¿ K2049DC; v)¿¿¿¿¿ K2049DD; w)¿¿¿ K2049DF; x)¿¿¿¿¿ P2037DAED; y)¿¿¿¿¿ P2037DBED; z)¿¿¿¿¿ P2037DED; aa)¿¿ To be provided
Why was it recalled?
GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM structured reports (i.e. preliminary, final, and/or addendum) stored in different series.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
a)¿¿¿¿¿2089507-120, UDI/DI 840682102988, Installed Product ID Numbers: JP-570093-Centricity Universal Viewer Zero Footprint / ZFP-02368762; b)¿¿¿¿ 2089507-129, UDI/DI 840682102988, Installed Product ID Numbers: 332068-Centricity Universal Viewer Zero Footprint / ZFP-19605736, 332068-Centricity Universal Viewer Zero Footprint / ZFP-20274641, RU9594-Centricity Universal Viewer Zero Footprint / ZFP-19628991; c)¿¿¿¿¿ 2089507-131, UDI/DI 840682102988, Installed Product ID Numbers: 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348317, 2722622-Centricity Universal Viewer Zero Footprint / ZFP-19663680, RU3232-Centricity Universal Viewer Zero Footprint / ZFP-20080525, RU1857-Centricity Universal Viewer Zero Footprint / ZFP-20022263; d)¿¿¿¿ 2089507-135, UDI/DI 840682102988, Installed Product ID Numbers: 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555361, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555362, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555363, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555364, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555365, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555367, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-21286328, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-21286332, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-21767150, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-21770700, 3480-29-Centr
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0039-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.