Z-1911-2019Class II

Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic...

Name: Z-1911-2019 Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic...
Creator: GE Healthcare, LLC
Published: 2019-05-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-05-16 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution... on 2019-05-16. FDA classified it as Class II and gives the reason as "There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1911-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-16
Posted: 2019-07-01
Terminated: 2023-04-14
Recalling firm: GE Healthcare
Product: Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
Root cause tag: design
FDA root cause: Device Design
Action: On May 20, 2019, the firm, GE Healthcare, sent an " URGENT MEDICAL DEVICE CORRECTION" letter date 5/20/2019 to their consignees. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: discontinue use of the UV study management functionality for study split/study info updates until a correction is available and to wait for a GE representative to contact them to arrange for the correction. 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: 92 (47 US 103 OUS)
Distribution: Worldwide Distribution: US (nationwide) to states of: FL, GA, IL, IN, LA, MA, MO, NJ, NY, OR, PA, SC, SD, TX, and WA; and countries of : Brazil, Canada, Chile, France, French Polynesia, Germany, India, Italy, Japan, Kuwait, Lebanon, Singapore, Spain and United Kingdom.
Product codes and lots: UDI # 840682104807 Model # 2098268-001 Software Version CPACS 6.0 SP9, CPACS 6.0 SP9.0.1 and CPACS 6.0 SP9.0.1.5

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1911-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1910-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-01
Z-1911-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-01

Product code LLZ

K110875Class IICentricity PacsGE Healthcare / cleared 2011-05-05

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)