Z-2712-2017 Class II Terminated
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
- 28 units
Product Description
APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 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 Numbers: a) JHA16X2002, HAB16Z2001, HAB16Z2002, HAB16Z2003, HAB16Z2004, HAB16Z2005, HAB1732007, HAB1732009 b) HAB16Z2002, HAB16Z2003, HAB1712006, HAB1712007, HAB1712008, HAB1712009, HAB1712010, HAB1722011, HAB1722012, HAB1732013, HAB1732014, HAB1732015, HAB1732016, HAB1732017, HAB1732018, HAB1732020, HAB1732021, HAB1732025, HAB1732027, HAB1732030