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Open, Classified

Centricity Cardiology CA1000

FDA Recall Z-1232-2022 · Posted 2022-06-03

Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2022-04-28
Product Quantity601 units

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.

Firm 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.

Root Cause

Software design

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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