Z-0484-2019 Class II Terminated
FDA device recall Z-0484-2019 was initiated by GE Healthcare, LLC on Sep 25, 2018 and is designated Class II. Reason for recall: Potential electric leakage affecting the user. The recall status is terminated (terminated Jul 13, 2020). Affected quantity: 1,724 devices total.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 28, 2018
- Initiation Date
- Sep 25, 2018
- Termination Date
- Jul 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,724 devices total
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution. US Nationwide, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Honduras, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
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-0484-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026