GE Healthcare, LLC: Medical Device Recall in 2022 - (Recall #: Z-1233-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Centricity PACS RA1000

Product Classification:

Class II

Date Initiated: April 28, 2022

Date Posted: June 15, 2022

Recall Number: Z-1233-2022

Event ID: 90136

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.

Status: Ongoing

Product Quantity: 676 units

Code Information:

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)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated