Z-0463-2019 Class I Terminated
FDA device recall Z-0463-2019 was initiated by GE Healthcare, LLC on Oct 5, 2018 and is designated Class I. Reason for recall: The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for… The recall status is terminated (terminated Apr 29, 2024). Affected quantity: 1140 units (307 units in US).
Recall Details
- Product Type
- Devices
- Report Date
- Dec 12, 2018
- Initiation Date
- Oct 5, 2018
- Termination Date
- Apr 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1140 units (307 units in US)
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: US (Nationwide) including Puerto Rico, and to countries of: Albania, Argentina, Australia, Austria, Bangladesh, Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Honduras, Hungary, India, Indonesia, Iraq, Italy, Japan, Kazakhstan, Korea (Republic of), Kuwait, Latvia, Lebanon, Libya, Malaysia, Maldives, Mexico, Myanmar, Nepal, Netherlands, Nicaragua, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, 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-0463-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026