Z-0329-2022 Class II Terminated
FDA device recall Z-0329-2022 was initiated by GE Healthcare, LLC on October 15, 2021 and is designated Class II. Reason for recall: There is a potential to display incomplete patient imaging study. The recall status is terminated (terminated August 17, 2026). Affected quantity: 638 devices.
Recall Details
- Product Type
- Devices
- Report Date
- December 8, 2021
- Initiation Date
- October 15, 2021
- Termination Date
- August 17, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 638 devices
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WA, and WV. The countries of Argentina, Aruba, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Panama, Qatar, Russia, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.