FDA · Medical device recall

Centricity Universal Viewer Zero Footprint Client and 4 more products

June 15, 2022 Class II

Date: June 15, 2022
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Ongoing
Filed by: GE Healthcare, LLC
Reason: 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.
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

5 products in this recall

Centricity Universal Viewer Zero Footprint Client

Product: Centricity Universal Viewer Zero Footprint Client
Quantity: 488 units
Codes and lots: Software Version 6.0 SP11 through 6.0 SP11.4; GTIN/DI: 00840682102988; Codes: 2089507-1XX
Recall started: April 28, 2022
Device type: System, Image Processing, Radiological
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-1229-2022

Centricity Enterprise Web

Product: Centricity Enterprise Web
Quantity: 536 units
Codes and lots: Software Versions 3.0 through 3.0 SP14d, 4.0 through 4.0 Spa6c and 4.0 Spa7b; Codes: 2027870-0XX, 2049944-0XX, 2068692-0XX.
Recall started: April 28, 2022
Device type: System, Image Processing, Radiological
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-1230-2022

Centricity Radiology RA600

Product: Centricity Radiology RA600
Quantity: 1,332 units
Codes and lots: 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)
Recall started: April 28, 2022
Device type: System, Image Processing, Radiological
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-1231-2022

Centricity Cardiology CA1000

Product: Centricity Cardiology CA1000
Quantity: 601 units
Codes and lots: a. Software Version 1.0 through 1.0 SP, No GTIN/DI (Code: 2022296-0XX); b. Software Version 2.0 through 2.0 SP14H, GTIN/DI: 00840682125260 (Codes: 2038437-0XX, 2097190-0XX)
Recall started: April 28, 2022
Device type: System, Image Processing, Radiological
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-1232-2022

Centricity PACS RA1000

Product: Centricity PACS RA1000
Quantity: 676 units
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)
Recall started: April 28, 2022
Device type: System, Image Processing, Radiological
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-1233-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1229-2022, Z-1230-2022, Z-1231-2022, Z-1232-2022, Z-1233-2022. The agency record governs; check it and the company before acting.

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