Z-0852-2021 Class II Terminated
FDA device recall Z-0852-2021 was initiated by Philips North America, LLC on November 19, 2020 and is designated Class II. Reason for recall: A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient. The recall status is terminated (terminated April 19, 2023). Affected quantity: 2714.
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2021
- Initiation Date
- November 19, 2020
- Termination Date
- April 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2714
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, Algeria, Argentina, Australia, Bahrain, Austria, Belgium, Brazil, China, Columbia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Kuwait, Latvia, Libya, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, United Kingdom, Venezuela.