Z-0123-2022 Class II Terminated
FDA device recall Z-0123-2022 was initiated by Philips Ultrasound Inc on September 21, 2021 and is designated Class II. Reason for recall: Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unne… The recall status is terminated (terminated April 12, 2024). Affected quantity: 107.
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- September 21, 2021
- Termination Date
- April 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 107
Product Description
Reason for Recall
Distribution Pattern
US: MI, AZ, IA, TN, OH, CO, WI, NY, NJ, NC, LA, IL, CA, KY, IN, MD, TX, PA. OUS: Denmark, Latvia, Belgium, Hungary, Argentina, Canada, Spain, Germany, Greece, Korea, Republic of Japan, France, Australia, Egypt, Switzerland, Italy, Senegal, Israel, Indonesia, Netherlands, Hong Kong, United Kingdom, Poland, Finland, India, New Zealand