Z-1129-2021 Class II Terminated
FDA device recall Z-1129-2021 was initiated by GE Healthcare, LLC on December 17, 2020 and is designated Class II. 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… The recall status is terminated (terminated January 9, 2023). Affected quantity: 96 units.
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
Reason for Recall
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.