RecallRadar

FDA Device recall Z-0023-2016

Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from…

On 2015-10-14 the FDA classified a Class II recall of Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from… by Ge Healthcare, citing images may be missing when a system parameter MapRoute is set to a value greater than 1.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0023-2016
ClassificationClass II
Statusterminated
Initiated2015-09-16
Published2015-10-14
Last updated2026-09-13 11:53 UTC
CompanyGe Healthcare
DistributionUS

Product

Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions 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.

Reason

Images may be missing when a system parameter MapRoute is set to a value greater than 1.

Identifiers

code_infoGE Centricity PACS-IW versions 3.5.0 through 3.7.3.9 Sp2, 3.7.3 Spa10, and 4.0.1

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0023-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.