Z-2161-2021 Class II Terminated
FDA device recall Z-2161-2021 was initiated by GE OEC Medical Systems, Inc on June 10, 2021 and is designated Class II. Reason for recall: There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable. The recall status is terminated (terminated May 9, 2024). Affected quantity: 3570 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 4, 2021
- Initiation Date
- June 10, 2021
- Termination Date
- May 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3570 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of CA, PA, WA, OH, LA, MS, AL, FL, MO, OK, AZ, NJ, CO, MI, NV, MN, KS, TN, NC, IL, MD, SC,GA, UT, WI, MT, AR, WV, ID,CT, IA, WY, VT, KY, DC, SD,ME, Virgin Islands and the countries of Colombia, Egypt, Peru, Chile, Spain, France, Germany, Hong Kong, Canada, Japan, Brazil, Turkey, United Arab Emirates, Singapore, Australia, Thailand, United Kingdom, Italy, Korea, Russia, CHINA, Romania, Nigeria, Czechia, Argentina, Taiwan, Bangladeh, Malaysia, Bosnia and Herzegovina, Poland, Belgium, Indonesia, Dominican Republic, Switzerland, Hungary, New Zealand, Vietnam, Mexico, India, Norway, Philippines, Ecuador, Lithuania, HONDURAS, Uruguay, Sweden, Croatia, Jamaica, Kuwait, Ethiopia, Saudi Arabia, Finland, Bahamas, Trinidad and Tobago, Pakistan, Slovakia, Costa Rica, Israel, Panama, Greece, South Africa and DENMARK.