Class 2 Device Recall Centricity Radiology RA600

• Date Initiated by Firm: April 28, 2022
• Date Posted: June 03, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1231-2022
• Recall Event ID: 90136
• 510(K)Number: K042525 K063628
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Centricity Radiology RA600
• Code Information: a. Software Version 7.0 through 7.0 SP, No GTIN/DI (Code: 2022296-0XX); b. Software Version 8.0 through 8.0 SP14H, GTIN/DI: 00840682125260 (Codes: 2038437-0XX, 2097190-0XX)
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: GE Healthcare Service; 800-437-1171
• Manufacturer 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.
• FDA Determined 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 Recall.85460@ge.com. 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: 1,332 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LLZ and Original Applicant = GE HEALTHCARE INTEGRATED IT SOLUTIONS; 510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES