Z-0944-2021 Class II Terminated
FDA device recall Z-0944-2021 was initiated by Philips Ultrasound Inc on December 16, 2020 and is designated Class II. Reason for recall: The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is enabled the color box shows flow… The recall status is terminated (terminated March 15, 2023). Affected quantity: 607 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2021
- Initiation Date
- December 16, 2020
- Termination Date
- March 15, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 607 units
Product Description
Reason for Recall
Distribution Pattern
US - AL, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE,NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI and WV OUS- Austria, Australia, Belgium, Canada, Chezh Republic, Croatia, Denmark, Egypt, Finland, France, Hong Kong, Indonesia, India, Ireland, Italy, Japan, Latvia, Lithuania, Malta, Mexico, Netherlands, Norway, Poland, Romania, Russia, Senegal, Slovenia, Sri Lanka, South Africa, Switzerland, Thailand, Turkey, UAE and United Kingdom.