Z-1616-2020 Class II Terminated
FDA device recall Z-1616-2020 was initiated by Philips North America, LLC on February 20, 2020 and is designated Class II. Reason for recall: Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing the O2 sen… The recall status is terminated (terminated September 21, 2021). Affected quantity: 2214 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2020
- Initiation Date
- February 20, 2020
- Termination Date
- September 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2214 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution and countries of Utd Arab Emir, Albania, Austria, Australia, Azerbaijan, Bulgaria, Brazil, White Russia, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary, Ireland, Israel, India, Iceland, Italy, Jamaica, Japan, Kyrgyzstan, Malaysia, Netherlands, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Uzbekistan, Viet Nam.