Z-1227-2022 Class I Ongoing
FDA device recall Z-1227-2022 was initiated by GE Healthcare, LLC on Apr 18, 2022 and is designated Class I. Reason for recall: Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply. The recall status is ongoing. Affected quantity: 88,379 batteries.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 15, 2022
- Initiation Date
- Apr 18, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88,379 batteries
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: US (nationwide) to AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and OUS (internationally) to Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Cote D'Ivoire, Mexico, Uruguay, United Kingdom, United Arab Emirates, Turkey, Thailand, Tanzania, Sweden, Spain, Singapore, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Panama, Omar, Norway, Nigeria, Nicaragua, New Zealand, Netherlands, Malaysia, Latvia, Kuwait, Korea, Kenya, Kazakhstan, Japan, Italy, Ireland, Indonesia, India, Hungary, Germany, France, Finland, Estonia, Egypt, Ecuador, Denmark, Czech Republic.
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-1227-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026