Z-1286-2022 Class II Ongoing
FDA device recall Z-1286-2022 was initiated by GE Healthcare, LLC on Apr 25, 2022 and is designated Class II. Reason for recall: Backup batteries can fail earlier than their estimated life. The recall status is ongoing. Affected quantity: 88,347 batteries.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 6, 2022
- Initiation Date
- Apr 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88,347 batteries
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Italy, Japan, Kazakhstan, Kenya, Korea, Kuwait, Lao PDR, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Nepal, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and 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-1286-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026