(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
Reported: August 31, 2022 Initiated: July 15, 2022 #Z-1566-2022
Product Description
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
Reason for Recall
Inaccurate Distance and Area measurements with use of Global Stack viewport.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 1,690 devices
- Distribution
- Distribution was made to AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, WA, WI, and WV. There was government distribution and no military distribution. Foreign distribution was made to Argentina, Aruba, Australia, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, South Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, Panama, Peru, Poland, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.. Recalled by GE Healthcare, LLC. Units affected: 1,690 devices.
Why was this product recalled? ▼
Inaccurate Distance and Area measurements with use of Global Stack viewport.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2022. Severity: Moderate. Recall number: Z-1566-2022.
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