Home / Recalls / GE Healthcare, LLC / Z-1129-2021

Z-1129-2021 Class II Terminated

Recalled by GE Healthcare, LLC — Waukesha, WI

Recall Details

Product Type
Devices
Report Date
February 24, 2021
Initiation Date
December 17, 2020
Termination Date
January 9, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
96 units

Product Description

System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition

Reason for Recall

GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.

Distribution Pattern

Worldwide - US Nationwide Distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NV, NY, NH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV; In the countries of Algeria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia, Denmark, Estonia, Finland, France, Gabon, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (Republic Of), Kuwait, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, Viet Nam.

Code Information

Model Numbers: 5590000-20: REV2A1900002CN, REV2A2000013CN, REV2A2000025CN, REV2A2000006CN, REV2A2000003CN, REV2A2000015CN, REV2A1900003CN, REV2A2000007CN, REV2A2000022CN, REV2A2000010CN, REV2A2000030CN, REV2A2000029CN, REV2A2000017CN, REV2A2000001CN, REV2A2000002CN, REV2A2000031CN, REV2A2000020CN, REV2A2000024CN, REV2A2000023CN, REV2A2000012CN, REV2A2000016CN, REV2A1900001CN, REV2A2000027CN, REV2A2000028CN, REV2A2000018CN, REV2A1900005CN, REV2A2000009CN, REV2A2000026CN, REV2A2000021CN, REV2A2000011CN 5590000-21: xxx, xxx, xxx* (66 units) *serial number information current as of 01/21/2021.

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  • Z-1475-2026 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: (January 16, 2026)
  • Z-0935-2026 Class II — GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processin (November 3, 2025)
  • Z-1483-2025 Class II — GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; (February 19, 2025)
  • Z-1486-2025 Class II — GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 203390 (February 19, 2025)
  • Z-1485-2025 Class II — GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-0 (February 19, 2025)
  • Z-1484-2025 Class II — GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; (February 19, 2025)
  • Z-1487-2025 Class II — GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers (February 19, 2025)
  • Z-0318-2025 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2 (October 3, 2024)
  • Z-0039-2025 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/C (August 29, 2024)