Z-2502-2021Class II

Centricity PACS-IW with Universal Viewer -

Name: Z-2502-2021 Centricity PACS-IW with Universal Viewer -
Creator: GE Healthcare, LLC
Published: 2021-08-06
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-08-06 / Open, Classified / root cause: software

FDA source

GE Healthcare, LLC began a recall of Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources on 2021-08-06. FDA classified it as Class II and gives the reason as "Image acquisition failures and synchronization failure with the Centricity Enterprise Archive". 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-2502-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-08-06
Posted: 2021-09-22
Recalling firm: GE Healthcare
Product: Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Root cause tag: software
FDA root cause: Software design
Action: This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected software versions on August 06, 2021. This letter informs customers of the issues and provides safety instructions. GE Healthcare will correct the issue through a product change. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 392 (219 US; 173 OUS) all products
Distribution: AK, AZ, CA, CO, DE, FL, GA, IA, IN, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, WA, WI, WV and WY. Austria, Brazil, Canada, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Netherlands, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Kingdom and Uruguay.
Product codes and lots: 2068177-001 (Centricity PACS-IW with Universal Viewer software versions 5.0.x with PACS-IW foundation) System ID: 083055248481416, 1-121967267, 1-429329281, DGC19607785, HC3062UV01, HCIT1401012UW, HCIT4331279UV, PACS-IW-127, PACS-IW-219, PACS-IW-2770, PACS-IW-323, PACS-IW-421, RICHMONDU14767331, RICHMONDU15531177N1, X1347906 / X1347909, X1347906 / X1347909, YP315021, ZA2412PAC21 and ZA2533PAC1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2502-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2502-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-22
Z-2503-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-22

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)