FDA Device recall Z-2712-2017
APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
- FDA Device
- Class II
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class II recall of APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system by Toshiba American Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2712-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-01 |
| Published | 2017-07-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | US |
Product
APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
Reason
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.
Identifiers
| code_info | Serial Numbers: a) JHA16X2002, HAB16Z2001, HAB16Z2002, HAB16Z2003, HAB16Z2004, HAB16Z2005, HAB1732007, HAB1732009 b…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2712-2017%22
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