Z-0793-2019 Class II Terminated
FDA device recall Z-0793-2019 was initiated by GE Healthcare, LLC on Dec 20, 2018 and is designated Class II. Reason for recall: When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on… The recall status is terminated (terminated Apr 9, 2021). Affected quantity: 297 (131 US; 166 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 13, 2019
- Initiation Date
- Dec 20, 2018
- Termination Date
- Apr 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 297 (131 US; 166 OUS)
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: US (nationwide) in states of: AZ, CA, CO, DE, FL, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, MT, NE, NJ, NV, NY, OH, PA, PR, SC, SD, TN, TX, VA, VT, and WI; and countries of: Antigua, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Cote d'Ivoire, France, Germany, Guatemala, India, Italy, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Panama, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0793-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026