Z-0721-2023Class II

Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms)...

Name: Z-0721-2023 Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms)...
Creator: GE Medical Systems, LLC
Published: 2022-10-28
License: https://open.fda.gov/license/

GE Healthcare / initiated 2022-10-28 / Open, Classified / root cause: software

FDA source

GE Medical Systems, LLC began a recall of Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources on 2022-10-28. FDA classified it as Class II and gives the reason as "There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0721-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-28
Posted: 2022-12-16
Recalling firm: GE Healthcare
Product: Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: GE Healthcare notified consignees on about 10/28/2022 via letter titled, "URGENT MEDICAL DEVICE CORRECTION - UPDATE." Consignees were instructed that the device can continued being used by following these instructions: 1) When a study is not present on the Study List, contact a GE Healthcare Service Representative for assistance in recovering the study. 2) In situations where study interpretation is time sensitive, interpret the study at the scanning unit or plan for an alternate means of reading studies for emergent cases. GE Healthcare will contact consignees to arrange for the correction. Consignees were also instructed to complete and return the acknowledgement form.
Quantity in commerce: 1 unit
Distribution: Nationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND, NJ, NY, OK, OR, SD, TX, WI, WV, WY. International distribution to Austria, Brazil, France, Germany, Ghana, Ireland, Italy, Kuwait, Poland, Saudi Arabia, South Africa, Spain, Switzerland, United Kingdom.
Product codes and lots: Installed Product ID: YP3150-Centricity Universal Viewer-01639018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0721-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0721-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-16
Z-0722-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-16

Product code LLZ

K123174Class IICentricity Pacs-Iw with Universal ViewerGE Healthcare / cleared 2012-11-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)