Z-2709-2017 Class II Terminated
FDA device recall Z-2709-2017 was initiated by Toshiba American Medical Systems Inc on May 1, 2017 and is designated Class II. Reason for recall: When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workst… The recall status is terminated (terminated October 11, 2023). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2017
- Initiation Date
- May 1, 2017
- Termination Date
- October 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
XARIO 200 TUS-X200 diagnostic ultrasound system
Reason for Recall
When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
Distribution Pattern
Nationwide Distribution
Code Information
Serial Number W5B1712472