Z-2594-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- August 2, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 system
Product Description
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Reason for Recall
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Distribution Pattern
U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
Code Information
Model: 88000025 GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002 Serial Numbers: F00002