Z-0915-2014 Class II Terminated
FDA device recall Z-0915-2014 was initiated by GE Healthcare on Dec 12, 2013 and is designated Class II. Reason for recall: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. The recall status is terminated (terminated Jun 1, 2015). Affected quantity: 48 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 12, 2014
- Initiation Date
- Dec 12, 2013
- Termination Date
- Jun 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
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-0915-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026