Z-1233-2022Class II

Centricity PACS RA1000

Name: Z-1233-2022 Centricity PACS RA1000
Creator: GE Healthcare, LLC
Published: 2022-04-28
License: https://open.fda.gov/license/

GE Healthcare / initiated 2022-04-28 / Open, Classified / root cause: software

FDA source

GE Healthcare, LLC began a recall of Centricity PACS RA1000 on 2022-04-28. FDA classified it as Class II and gives the reason as "Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values...". 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-1233-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-28
Posted: 2022-06-03
Recalling firm: GE Healthcare
Product: Centricity PACS RA1000
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare notified consignees on about 04/28/2022 via letter titled "URGENT MEDICAL DEVICE CORRECTION." The letter outlined two safety issues and instructed customers to continue to use the device in accordance with the User Manuals, but for issue #1, do not rely on measurements displayed in the viewer. They should manually calibrate the image to create a measurement calibration reference and then perform necessary measurements. For issue #2, do not perform measurements on lossy images. In both instances, customers were requested to complete and return the acknowledgment form to [email protected]. A second letter was sent to customers on about 02/24/2023, to provide instructions for downloading the user manual addendum for CWeb.
Quantity in commerce: 676 units
Distribution: Worldwide distribution. Nationwide distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International distribution to Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Bolivia, Plurinational State of, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, South, Kuwait, Lebanon, Malaysia, Malta, Mexico, Namibia, Netherlands, Nigeria, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Qatar, Russia, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Bolivarian Republic of, Vietnam
Product codes and lots: a. Software Version 3.0 through 3.2 SP8, No GTIN/DI (Code: 2051372-0XX, 2064678-0XX) b. Software Version 4.0 through 4.0 SP14, GTIN/DI 00840682124447 (Code: 2062264-0XX); c. 6.0 through 6.0 SP10.3, GTIN/DI: 00840682104821 (Code: 2094628-0XX); d. 7.0 through 7.0 SP0.0.4.7, GTIN/DI: 00840682145558 (Code: 5824366-0XX)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1233-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1229-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-03
Z-1230-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-03
Z-1231-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-03
Z-1232-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-03
Z-1233-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-03

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)