Centricity Universal Viewer Zero Footprint Client
FDA device recall Z-1229-2022 · posted 2022-06-03 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 488 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, P
- Date initiated
- 2022-04-28
- Date posted
- 2022-06-03
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT (K131977) | GE Healthcare | 2013-09-17 |