GE Healthcare Centricity Universal Viewer Zero Footprint Client…

Date

Oct. 16, 2024

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): 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)

Status

Ongoing

Filed by

GE Healthcare

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

Reason

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.

Distribution pattern

Worldwide distribution.

Quantity

1500 units

Codes and lots

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-Centricity Universal Viewer Zero Footprint / ZFP-21770743, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-19720328, 14398615-Centricity Universal Viewer Zero Footprint / ZFP-21286099, 082455140084-Centricity Universal Viewer Zero Footprint / ZFP-20697867, RU7950-Centricity Universal Viewer Zero Footprint / ZFP-02331578, RF2557-Centricity Universal Viewer Zero Footprint / ZFP-21209143, RU2636-Centricity Universal Viewer Zero Footprint / ZFP-20656772, RU1377-Centricity Universal Viewer Zero Footprint / ZFP-20613807, -Centricity Universal Viewer Zero Footprint / ZFP-02331243, RU1140-Centricity Universal Viewer Zero Footprint / ZFP-20278602, GPX234-Centricity Universal Viewer Zero Footprint / ZFP-24305099, GEE340-Centricity Universal Viewer Zero Footprint / ZFP-20641898, 81193-Centricity Universal Viewer Zero Footprint / ZFP-20274992; e)¿¿¿¿ 2089507-136, UDI/DI 840682102988, Installed Product ID Numbers: 103944-3-Centricity Universal Viewer Zero Footprint / ZFP-02286833, 4325-52-Centricity Universal Viewer Zero Footprint / ZFP-02345640, 2812599-Centricity Universal Viewer Zero Footprint / ZFP-20502391, 2812599-Centricity Universal Viewer Zero Footprint / ZFP-20502392, 2812599-Centricity Universal Viewer Zero Footprint / ZFP-20502393; f)¿¿¿¿¿¿ 2089507-140, UDI/DI 840682102988, Installed Product ID Numbers: 010120-Centricity Universal Viewer Zero Footprint / ZFP-00044252, 010120-Centricity Universal Viewer Zero Footprint / ZFP-00044253, 010120-Centricity Universal Viewer Zero Footprint / ZFP-00044254, JP-070098-Centricity Universal Viewer Zero Footprint / ZFP-20081084, JP-340137-Centricity Universal Viewer Zero Footprint / ZFP-20483713, JP-360037-Centricity Universal Viewer Zero Footprint / ZFP-19669327, JP-360037-Centricity Universal Viewer Zero Footprint / ZFP-19669329, 332068-Centricity Universal Viewer Zero Footprint / ZFP-20274654, 1363272-Centricity Universal Viewer Zero Footprint / ZFP-01286173; g)¿¿¿¿¿ 2089507-144, UDI/DI 840682102988, Installed Product ID Numbers: 1499-1-Centricity Universal Viewer Zero Footprint / ZFP-20495561, 1503586-Centricity Universal Viewer Zero Footprint / ZFP-21286303, 656341-Centricity Universal Viewer Zero Footprint / ZFP-20548333, 283046-Centricity Universal Viewer Zero Footprint / ZFP-20542523, 283043-Centricity Universal Viewer Zero Footprint / ZFP-20585448, 283043-Centricity Universal Viewer Zero Footprint / ZFP-20679068, 283043-Centricity Universal Viewer Zero Footprint / ZFP-20679070, 283046-Centricity Universal Viewer Zero Footprint / ZFP-20679073, 283046-Centricity Universal Viewer Zero Footprint / ZFP-20679084, 283043-Centricity Universal Viewer Zero Footprint / ZFP-20679091, 305612-Centricity Universal Viewer Zero Footprint / ZFP-16234652, 297162-Centricity Universal Viewer Zero Footprint / ZFP-16737454; h)¿¿¿¿ 2089507-145, UDI/DI 840682102988, Installed Product ID Numbers: 1495-1-Centricity Universal Viewer Zero Footprint / ZFP-02347655, 92317-Centricity Universal Viewer Zero Footprint / ZFP-01300703, 92317-Centricity Universal Viewer Zero Footprint / ZFP-01762799, IL1469-Centricity Universal Viewer Zero Footprint / ZFP-01451992, IL1469-Centricity Universal Viewer Zero Footprint / ZFP-18468924, IL1469-Centricity Universal Viewer Zero Footprint / ZFP-18468926, JP-270367-Centricity Universal Viewer Zero Footprint / ZFP-20501441, JP-270367-Centricity Universal Viewer Zero Footprint / ZFP-20501442, JP-270367-Centricity Universal Viewer Zero Footprint / ZFP-20536616, LB1000-Centricity Universal Viewer Zero Footprint / ZFP-01610285; i)¿¿¿¿¿¿ 2089507-149, UDI/DI 840682102988, Installed Product ID Numbers: 656687-Centricity Universal Viewer Zero Footprint / ZFP-21988753, 656687-Centricity Universal Viewer Zero Footprint / ZFP-22156472, 656687-Centricity Universal Viewer Zero Footprint / ZFP-22156473, 656687-Centricity Universal Viewer Zero Footprint / ZFP-22156474, 656687-Centricity Universal Viewer Zero Footprint / ZFP-22156475, 656687-Centricity Universal Viewer Zero Footprint / ZFP-22156476, 106416-2-Centricity Universal Viewer Zero Footprint / ZFP-20813957, GRN12-Centricity Universal Viewer Zero Footprint / ZFP-20869108, ZA2812-Centricity Universal Viewer Zero Footprint / ZFP-01300901, -Centricity Universal Viewer Zero Footprint / ZFP-21229880; j)¿¿¿¿¿¿ 2089507-153, UDI/DI 840682102988, Installed Product ID Numbers: 105906-2-Centricity Universal Viewer Zero Footprint / ZFP-19980067, 105920-1-Centricity Universal Viewer Zero Footprint / ZFP-02304839, 10908-4-Centricity Universal Viewer Zero Footprint / ZFP-00103231, 10908-4-Centricity Universal Viewer Zero Footprint / ZFP-00103232, 4263-3-Centricity Universal Viewer Zero Footprint / ZFP-00106869, 4263-3-Centricity Universal Viewer Zero Footprint / ZFP-00106870, 4263-5-Centricity Universal Viewer Zero Footprint / ZFP-01300798, 9896-1-Centricity Universal Viewer Zero Footprint / ZFP-19668387, 9896-1-Centricity Universal Viewer Zero Footprint / ZFP-20681261, 9896-1-Centricity Universal Viewer Zero Footprint / ZFP-20681262, 103203-12-Centricity Universal Viewer Zero Footprint / ZFP-20706186, 103203-12-Centricity Universal Viewer Zero Footprint / ZFP-20706187, 103203-12-Centricity Universal Viewer Zero Footprint / ZFP-20915426, 103203-12-Centricity Universal Viewer Zero Footprint / ZFP-20915427, 103203-12-Centricity Universal Viewer Zero Footprint / ZFP-20915429, 103203-12-Centricity Universal Viewer Zero Footprint / ZFP-21755197, 103203-12-Centricity Universal Viewer Zero Footprint / ZFP-21755198, 11056-1-Centricity Universal Viewer Zero Footprint / ZFP-00102233, 11056-1-Centricity Universal Viewer Zero Footprint / ZFP-00102234, 10147-2-Centricity Universal Viewer Zero Footprint / ZFP-20087516, 10147-2-Centricity Universal Viewer Zero Footprint / ZFP-20606564, 3846-3-Centricity Universal Viewer Zero Footprint / ZFP-00101406, 3846-3-Centricity Universal Viewer Zero Footprint / ZFP-00101409, 3846-3-Centricity Universal Viewer Zero Footprint / ZFP-20872747, 103944-3-Centricity Universal Viewer Zero Footprint / ZFP-02286832, 101454-1-Centricity Universal Viewer Zero Footprint / ZFP-20549409, 1187-12-Centricity Universal Viewer Zero Footprint / ZFP-02040789, 1187-12-Centricity Universal Viewer Zero Footprint / ZFP-02040790, 106286-2-Centricity Universal Viewer Zero Footprint / ZFP-19666529, 106286-2-Centricity Universal Viewer Zero Footprint / ZFP-19666742, 106286-2-Centricity Universal Viewer Zero Footprint / ZFP-19666743, 106286-2-Centricity Universal Viewer Zero Footprint / ZFP-19666744, 106286-2-Centricity Universal Viewer Zero Footprint / ZFP-19666746, 103413-1-Centricity Universal Viewer Zero Footprint / ZFP-00104999, 103413-1-Centricity Universal Viewer Zero Footprint / ZFP-02039875, 4642-6-Centricity Universal Viewer Zero Footprint / ZFP-02255116, 4642-6-Centricity Universal Viewer Zero Footprint / ZFP-19664725, 4642-6-Centricity Universal Viewer Zero Footprint / ZFP-20039104, 4642-6-Centricity Universal Viewer Zero Footprint / ZFP-20039105, 4642-6-Centricity Universal Viewer Zero Footprint / ZFP-20039106, 10283-1-Centricity Universal Viewer Zero Footprint / ZFP-00097952, 10283-1-Centricity Universal Viewer Zero Footprint / ZFP-14767336, 10283-1-Centricity Universal Viewer Zero Footprint / ZFP-14767580, 10283-1-Centricity Universal Viewer Zero Footprint / ZFP-20606898, 10283-1-Centricity Universal Viewer Zero Footprint / ZFP-21176044, 2457-1-Centricity Universal Viewer Zero Footprint / ZFP-00108169, 2457-1-Centricity Universal Viewer Zero Footprint / ZFP-02180905, 2457-1-Centricity Universal Viewer Zero Footprint / ZFP-20091449, 2457-1-Centricity Universal Viewer Zero Footprint / ZFP-22194555, 2457-1-Centricity Universal Viewer Zero Footprint / ZFP-22195259, 4203-4-Centricity Universal Viewer Zero Footprint / ZFP-19661470, 4203-4-Centricity Universal Viewer Zero Footprint / ZFP-21368341, 4203-4-Centricity Universal Viewer Zero Footprint / ZFP-21368342, 4203-4-Centricity Universal Viewer Zero Footprint / ZFP-21368343, 4203-4-Centricity Universal Viewer Zero Footprint / ZFP-21368349, 106361-2-Centricity Universal Viewer Zero Footprint / ZFP-22106308, 2387-10-Centricity Universal Viewer Zero Footprint / ZFP-01270499, 2387-10-Centricity Universal Viewer Zero Footprint / ZFP-01270501, 2387-10-Centricity Universal Viewer Zero Footprint / ZFP-01286806, 2387-10-Centricity Universal Viewer Zero Footprint / ZFP-01286807, 2387-10-Centricity Universal Viewer Zero Footprint / ZFP-01286808, 2387-10-Centricity Universal Viewer Zero Footprint / ZFP-01286809, 2387-10-Centricity Universal Viewer Zero Footprint / ZFP-02157027, 2387-10-Centricity Universal Viewer Zero Footprint / ZFP-21311264, 2387-10-Centricity Universal Viewer Zero Footprint / ZFP-21772293, 2387-10-Centricity Universal Viewer Zero Footprint / ZFP-21777824, 2387-10-Centricity Universal Viewer Zero Footprint / ZFP-21777825, 2387-22-Centricity Universal Viewer Zero Footprint / ZFP-01286812, 2387-22-Centricity Universal Viewer Zero Footprint / ZFP-02157028, 2387-26-Centricity Universal Viewer Zero Footprint / ZFP-14430145, 102250-1-Centricity Universal Viewer Zero Footprint / ZFP-20039163, 102250-1-Centricity Universal Viewer Zero Footprint / ZFP-20100435, 1118-1-Centricity Universal Viewer Zero Footprint / ZFP-01371407, 1118-1-Centricity Universal Viewer Zero Footprint / ZFP-01371408, 1118-1-Centricity Universal Viewer Zero Footprint / ZFP-02180335, 1118-1-Centricity Universal Viewer Zero Footprint / ZFP-02180336, 1118-1-Centricity Universal Viewer Zero Footprint / ZFP-21739655, 2387-17-Centricity Universal Viewer Zero Footprint / ZFP-01982831, 103442-1-Centricity Universal Viewer Zero Footprint / ZFP-19609716, 4314-1-Centricity Universal Viewer Zero Footprint / ZFP-14776668, 4314-1-Centricity Universal Viewer Zero Footprint / ZFP-14776669, 4314-1-Centricity Universal Viewer Zero Footprint / ZFP-14776670, 101872-4-Centricity Universal Viewer Zero Footprint / ZFP-01295303, 3475-2-Centricity Universal Viewer Zero Footprint / ZFP-01284909, 3475-2-Centricity Universal Viewer Zero Footprint / ZFP-01284910, 3677-6-Centricity Universal Viewer Zero Footprint / ZFP-01893388, 3677-6-Centricity Universal Viewer Zero Footprint / ZFP-20071931, 2403-7-Centricity Universal Viewer Zero Footprint / ZFP-01446989, 11042-1-Centricity Universal Viewer Zero Footprint / ZFP-01810752, 11042-1-Centricity Universal Viewer Zero Footprint / ZFP-20072339, 11042-1-Centricity Universal Viewer Zero Footprint / ZFP-20072346, 11042-6-Centricity Universal Viewer Zero Footprint / ZFP-20072348…

Recall started

Aug. 29, 2024

Device type

System, Image Processing, Radiological

Root cause (FDA)

Process control

What the company told customers

GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 08/29/2024 via mail. The notice explained the issue with the device, safety issue, and provided the following: "Actions to be taken by Customer/User: You can continue to use your device by following the recommendation below. To find the latest report, review all the reports available for the study in the Series Selector. Navigation to the series selection can be found in the User Manual under Section 2.4.3 of The Series Selector, with the subheading of Open a report/document. Please ensure all potential users in your facility are made aware of this safety notification and the recommended action." GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Recall number

Z-0039-2025

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0039-2025. The agency record governs; check it and the company before acting.