Centricity Universal Viewer Zero Footprint Client…

Date

Dec. 26, 2018

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

Terminated

Filed by

GE Healthcare, LLC

Product

Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect.

Reason

Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and vertically, the orientation markers appear correctly on the image to which they were applied. However, once new image rendering happens on this image or series (with scrolling; playing cin¿; maximizing or changing viewports/layouts; or synchronizing viewports and resizing the browser), the new image orientation is correctly maintained but the display of orientation markers can become incorrect. Issue #2 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a, SP8.0.2, SP9 and SP9.0.1. When an image in a series is flipped and then rotated in Zero Footprint Viewer (ZFP), the orientation markers appear correctly on the image to which they were applied. However, once you navigate to another image in the series and the image you navigated to has a different orientation than the prior image from which you navigated, the new image orientation is correctly maintained but the display of orientation markers can become incorrect.

Distribution pattern

Worldwide

Quantity

508 units

Codes and lots

Serial Number UDI 4532-2-Centricity Universal Viewer Zero Footprint / ZFP-01889426 (01)00840682102988(10)6.0SP82093796001D 4532-2-Centricity Universal Viewer Zero Footprint / ZFP-01889426 (01)00840682102988(10)6.0SP82093796001D 10213-1-Centricity Universal Viewer Zero Footprint / ZFP-01815213 (01)00840682102988(10)6.0SP72093796001D 10711-1-Centricity Universal Viewer Zero Footprint / ZFP-01970566 (01)00840682102988(10)6.0SP72093796001D 100620-2-Centricity Universal Viewer Zero Footprint / ZFP-00099694 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00105531 (01)00840682102988(10)6.0SP7.0.22093796001D 3730-1-Centricity Universal Viewer Zero Footprint / ZFP-01803680 (01)00840682102988(10)6.0SP7.0.22093796001D 3730-1-Centricity Universal Viewer Zero Footprint / ZFP-01803680 (01)00840682102988(10)6.0SP7.0.22093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00102068 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00105530 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00105531 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-00105531 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-02025410 (01)00840682102988(10)6.0SP9.0.12093796001D 103960-2-Centricity Universal Viewer Zero Footprint / ZFP-02025461 (01)00840682102988(10)6.0SP9.0.12093796001D 105412-2-Centricity Universal Viewer Zero Footprint / ZFP-01978386 (01)00840682102988(10)6.0SP92093796001D 3846-2-Centricity Universal Viewer Zero Footprint / ZFP-01613236 (01)00840682102988(10)6.0SP72093796001D 2317-3-Centricity Universal Viewer Zero Footprint / ZFP-00165279 (01)00840682102988(10)6.0SP7.0.22093796001D 2317-3-Centricity Universal Viewer Zero Footprint / ZFP-00165278 (01)00840682102988(10)6.0SP7.0.22093796001D 1202-8-Centricity Universal Viewer Zero Footprint / ZFP-00100999 (01)00840682102988(10)6.0SP7.0.22093796001D 3805-8-Centricity Universal Viewer Zero Footprint / ZFP-02098759 (01)00840682102988(10)6.0SP8.0.22093796001D 3805-8-Centricity Universal Viewer Zero Footprint / ZFP-02098758 (01)00840682102988(10)6.0SP8.0.22093796001D 3805-8-Centricity Universal Viewer Zero Footprint / ZFP-02098757 (01)00840682102988(10)6.0SP8.0.22093796001D 3805-8-Centricity Universal Viewer Zero Footprint / ZFP-02098755 (01)00840682102988(10)6.0SP8.0.22093796001D 101764-1-Centricity Universal Viewer Zero Footprint / ZFP-01432060 (01)00840682102988(10)6.0SP7.0.12093796001D 101764-1-Centricity Universal Viewer Zero Footprint / ZFP-01432060 (01)00840682102988(10)6.0SP7.0.12093796001D 101764-1-Centricity Universal Viewer Zero Footprint / ZFP-01432060 (01)00840682102988(10)6.0SP7.0.12093796001D 101764-1-Centricity Universal Viewer Zero Footprint / ZFP-01432060 (01)00840682102988(10)6.0SP72093796001D 101764-1-Centricity Universal Viewer Zero Footprint / ZFP-01432060 (01)00840682102988(10)6.0SP72093796001D 101764-1-Centricity Universal Viewer Zero Footprint / ZFP-01432060 (01)00840682102988(10)6.0SP72093796001D 103944-3-Centricity Universal Viewer Zero Footprint / ZFP-01477454 (01)00840682102988(10)6.0SP8.0.22093796001D 10345-9-Centricity Universal Viewer Zero Footprint / ZFP-01425634 (01)00840682102988(10)6.0SP8.0.22093796001D 10345-9-Centricity Universal Viewer Zero Footprint / ZFP-01425634 (01)00840682102988(10)6.0SP8.0.22093796001D 10345-1-Centricity Universal Viewer Zero Footprint / ZFP-01419025 (01)00840682102988(10)6.0SP8.0.22093796001D 101349-2-Centricity Universal Viewer Zero Footprint / ZFP-00107435 (01)00840682102988(10)6.0SP7.0.22093796001D 101349-2-Centricity Universal Viewer Zero Footprint / ZFP-02098718 (01)00840682102988(10)6.0SP7.0.22093796001D 103944-3-Centricity Universal Viewer Zero Footprint / ZFP-01477454 (01)00840682102988(10)6.0SP9.0.12093796001D 13132-11-Centricity Universal Viewer Zero Footprint / ZFP-01445043 (01)00840682102988(10)6.0SP72093796001D 13132-11-Centricity Universal Viewer Zero Footprint / ZFP-01445043 (01)00840682102988(10)6.0SP72093796001D 13132-11-Centricity Universal Viewer Zero Footprint / ZFP-01445043 (01)00840682102988(10)6.0SP72093796001D 10691-2-Centricity Universal Viewer Zero Footprint / ZFP-01817128 (01)00840682102988(10)6.0SP7.0.22093796001D 10691-2-Centricity Universal Viewer Zero Footprint / ZFP-02095550 (01)00840682102988(10)6.0SP7.0.22093796001D 1215-20-Centricity Universal Viewer Zero Footprint / ZFP-00105026 (01)00840682102988(10)6.0SP72093796001D 1215-20-Centricity Universal Viewer Zero Footprint / ZFP-00105026 (01)00840682102988(10)6.0SP72093796001D 1215-20-Centricity Universal Viewer Zero Footprint / ZFP-00105026 (01)00840682102988(10)6.0SP72093796001D 11619-2-Centricity Universal Viewer Zero Footprint / ZFP-01810676 (01)00840682102988(10)6.0SP72093796001D 11619-2-Centricity Universal Viewer Zero Footprint / ZFP-01810676 (01)00840682102988(10)6.0SP72093796001D 11619-2-Centricity Universal Viewer Zero Footprint / ZFP-01810676 (01)00840682102988(10)6.0SP72093796001D 101499-1-Centricity Universal Viewer Zero Footprint / ZFP-01797031 (01)00840682102988(10)6.0SP7.0.22093796001D 101499-1-Centricity Universal Viewer Zero Footprint / ZFP-02091471 (01)00840682102988(10)6.0SP72093796001D 102742-1-Centricity Universal Viewer Zero Footprint / ZFP-01804953 (01)00840682102988(10)6.0SP7.0.12093796001D 102742-1-Centricity Universal Viewer Zero Footprint / ZFP-01804952 (01)00840682102988(10)6.0SP7.0.12093796001D 102742-1-Centricity Universal Viewer Zero Footprint / ZFP-01804952 (01)00840682102988(10)6.0SP7.0.12093796001D 3212-8-Centricity Universal Viewer Zero Footprint / ZFP-01740249 (01)00840682102988(10)6.0SP72093796001D 3212-8-Centricity Universal Viewer Zero Footprint / ZFP-01740249 (01)00840682102988(10)6.0SP72093796001D 3212-8-Centricity Universal Viewer Zero Footprint / ZFP-01740249 (01)00840682102988(10)6.0SP72093796001D 1049-5-Centricity Universal Viewer Zero Footprint / ZFP-01477460 (01)00840682102988(10)6.0SP8.0.22093796001D 1049-5-Centricity Universal Viewer Zero Footprint / ZFP-01477460 (01)00840682102988(10)6.0SP7.0.12093796001D 1049-5-Centricity Universal Viewer Zero Footprint / ZFP-01477460 (01)00840682102988(10)6.0SP7.0.12093796001D 1049-5-Centricity Universal Viewer Zero Footprint / ZFP-01477460 (01)00840682102988(10)6.0SP7.0.12093796001D 1049-5-Centricity Universal Viewer Zero Footprint / ZFP-01477460 (01)00840682102988(10)6.0SP7.0.12093796001D 10547-2-Centricity Universal Viewer Zero Footprint / ZFP-01294055 (01)00840682102988(10)6.0SP72093796001D 10547-2-Centricity Universal Viewer Zero Footprint / ZFP-01294055 (01)00840682102988(10)6.0SP72093796001D 10547-2-Centricity Universal Viewer Zero Footprint / ZFP-01294055 (01)00840682102988(10)6.0SP72093796001D 9915-2-Centricity Universal Viewer Zero Footprint / ZFP-01459010 (01)00840682102988(10)6.0SP7.0.22093796001D 3228-12-Centricity Universal Viewer Zero Footprint / ZFP-01451967 (01)00840682102988(10)6.0SP7.0.12093796001D 3228-12-Centricity Universal Viewer Zero Footprint / ZFP-01451967 (01)00840682102988(10)6.0SP72093796001D 3228-12-Centricity Universal Viewer Zero Footprint / ZFP-01451967 (01)00840682102988(10)6.0SP7.0.22093796001D Entitlement ID 710d-5e4e-c28d-4be1-a48f-52ca-60cd-c333 (01)00840682102988(10)6.0SP9.0.12093796001D 4220-1-Centricity Universal Viewer Zero Footprint / ZFP-01404916 (01)00840682102988(10)6.0SP82093796001D 4220-1-Centricity Universal Viewer Zero Footprint / ZFP-01404916 (01)00840682102988(10)6.0SP82093796001D 4220-1-Centricity Universal Viewer Zero Footprint / ZFP-01404916 (01)00840682102988(10)6.0SP82093796001D 4220-1-Centricity Universal Viewer Zero Footprint / ZFP-01404916 (01)00840682102988(10)6.0SP82093796001D 4220-1-Centricity Universal Viewer Zero Footprint / ZFP-01404916 (01)00840682102988(10)6.0SP82093796001D 4220-1-Centricity Universal Viewer Zero Footprint / ZFP-01404916 (01)00840682102988(10)6.0SP82093796001D 4220-1-Centricity Universal Viewer Zero Footprint / ZFP-01404916 (01)00840682102988(10)6.0SP82093796001D 3480-7-Centricity Universal Viewer Zero Footprint / ZFP-00555367 (01)00840682102988(10)6.0SP8.0.22093796001D 3480-7-Centricity Universal Viewer Zero Footprint / ZFP-00555366 (01)00840682102988(10)6.0SP8.0.22093796001D 3480-7-Centricity Universal Viewer Zero Footprint / ZFP-00555365 (01)00840682102988(10)6.0SP8.0.22093796001D 3480-7-Centricity Universal Viewer Zero Footprint / ZFP-00555364 (01)00840682102988(10)6.0SP8.0.22093796001D 3480-7-Centricity Universal Viewer Zero Footprint / ZFP-00555363 (01)00840682102988(10)6.0SP8.0.22093796001D 3480-7-Centricity Universal Viewer Zero Footprint / ZFP-00555362 (01)00840682102988(10)6.0SP8.0.22093796001D 3480-7-Centricity Universal Viewer Zero Footprint / ZFP-00555361 (01)00840682102988(10)6.0SP8.0.22093796001D 3876-1-Centricity Universal Viewer Zero Footprint / ZFP-00103824 (01)00840682102988(10)6.0SP8.0.22093796001D 1198-18-Centricity Universal Viewer Zero Footprint / ZFP-01370311 (01)00840682102988(10)6.0SP9.0.12093796001D 3480-7-Centricity Universal Viewer Zero Footprint / ZFP-00555361 (01)00840682102988(10)6.0SP9.0.12093796001D 3480-7-Centricity Universal Viewer Zero Footprint / ZFP-00555362 (01)00840682102988(10)6.0SP9.0.12093796001D 3480-7-Centricity Universal Viewer Zero Footprint / ZFP-00555363 (01)00840682102988(10)6.0SP9.0.12093796001D 3480-7-Centricity Universal Viewer Zero Footprint / ZFP-00555364 (01)00840682102988(10)6.0SP9.0.12093796001D 3480-7-Centricity Universal Viewer Zero Footprint / ZFP-00555365 (01)00840682102988(10)6.0SP9.0.12093796001D 3480-7-Centricity Universal Viewer Zero Footprint / ZFP-00555366 (01)00840682102988(10)6.0SP9.0.12093796001D 3480-7-Centricity Universal Viewer Zero Footprint / ZFP-00555367 (01)00840682102988(10)6.0SP9.0.12093796001D To be provided (01)00840682102988(10)6.0SP9012093796001D 3455-3-Centricity Universal Viewer Zero Footprint / ZFP-01813654 (01)00840682102988(10)6.0SP7.0.12093796001D 3455-3-Centricity Universal Viewer Zero Footprint / ZFP-01813647 (01)00840682102988(10)6.0SP7.0.12093796001D 3455-3-Centricity Universal Viewer Zero Footprint / ZFP-01813644 (01)00840682102988(10)6.0SP7.0.12093796001D 2387-17-Centricity Universal Viewer Zero Footprint / ZFP-01982831 (01)00840682102988(10)6.0SP72093796001D 2387-15-Centricity Universal Viewer Zero Footprint / ZFP-01270499 (01)00840682102988(10)6.0SP7.0.22093796001D 2387-15-Centricity Universal Viewer Zero Footprint / ZFP-01270499 (01)00840682102988(10)6.0SP92093796001D 2219-7-Centricity Universal Viewer Zero Footprint / ZFP-01796537 (01)00840682102988(10)6.0SP8.0.12093796001D 2219-7-Centricity Universal Viewer Zero Footprint / ZFP-01796537 (01)00840682102988(10)6.0SP7.0.12093796001D 2219-7-Centricity Universal Viewer Zero Footprint / ZFP-01796537 (01)00840682102988(10)6.0SP7.0.12093796001D 2219-7-Centricity Universal Viewer Zero Footprint / ZFP-00347513 (01)00840682102988(10)6.0SP8.0.12093796001D 2219-7-Centricity Universal Viewer Zero Footprint / ZFP-00347507 (01)00840682102988(10)6.0SP8.0.12093796001D 2219-7-Centricity Universal Viewer Zero Footprint / ZFP-00347506 (01)00840682102988(10)6.0SP8.0.12093796001D 2219-7-Centricity Universal Viewer Zero Footprint / ZFP-00347505 (01)00840682102988(10)6.0SP8.0.12093796001D 2219-7-Centricity Universal Viewer Zero Footprint / ZFP-00347503 (01)00840682102988(10)6.0SP8.0.12093796001D 1542-5-Centricity Universal Viewer Zero Footprint / ZFP-01970562 (01)00840682102988(10)6.0SP7.0.12093796001D 1542-5-Centricity Universal Viewer Zero Footprint / ZFP-01970562 (01)00840682102988(10)6.0SP7.0.12093796001D 1207-13-Centricity Universal Viewer Zero Footprint / ZFP-01980284 (01)00840682102988(10)6.0SP72093796001D 1207-13-Centricity Universal Viewer Zero Footprint / ZFP-00111071 (01)00840682102988(10)6.0SP7.0.22093796001D 1609-1-Centricity Universal Viewer Zero Footprint / ZFP-00104759 (01)00840682102988(10)6.0SP72093796001D…

Recall started

Nov. 9, 2018

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

The firm issued the medical device correction notices on 11/09/2018 by letter. The letter outlined the problems and provided work-around strategies to be employed until a product modification is available to correct the issues.

Recall number

Z-0641-2019

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

Source: FDA · Medical device enforcement report, recall number Z-0641-2019. The agency record governs; check it and the company before acting.