Z-0448-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 18, 2020
- Initiation Date
- August 5, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product Description
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - 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
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Distribution Pattern
US Nationwide distribution including in the state of TX.
Code Information
Serial Numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004