CLASS II Device recall · Reported 19 Jul 2017 · FDA Enforcement Report
Aplio 300 Tus-A300 diagnostic ultrasound system recalled
Toshiba American Medical Systems is recalling Aplio 300 Tus-A300 diagnostic ultrasound system, distributed nationwide in the US. The recall was initiated on 1 May 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2710-2017
- FDA event ID
- 77599
- Recalling firm
- Toshiba American Medical Systems, Tustin, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 May 2017
- FDA classified
- 10 Jul 2017
- Reported
- 19 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 1 May 2017 | Recall initiated by company | |
| 10 Jul 2017 | Classified by FDA | +70 days |
| 19 Jul 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
APLIO 300 TUS-A300 diagnostic ultrasound system
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: AAC1692086, AAC1692087, AAC1692088, AAC1692089, AAC1692090, AAC16Y2091, AAC16Y2092, AAC16Y2093, AAC16Y2094, AAC16Y2095, AAC16Y2096, AAC16Y2097, AAC16Y2098, AAC16Y2099, AAC16Y2100, AAD16Z2101, AAD16Z2102, AAD16Z2103, AAD16Z2104, AAD16Z2105, AAD1712106, AAD1712107, AAD1712108, AAD1712109, AAD1712110, AAD1712111, AAD1712112, AAD1722114, AAD1722115, AAD1722116, AAD1722117, AAA1652011, AAA1652012, AAA1652013, AAA1652014, AAA1652015, AAA1672026, AAA1672027, AAA1672028, AAA1672029, AAA1672030, AAA1672031, AAA1672032, AAA1672033, AAA1672034, AAA1672035, AAA1672036, AAA1672037, AAA1672038, AAA1672040, AAA1682041, AAA1682042, AAA1682043, AAA1682044, AAA1682045, AAA1682046, AAA1682047, AAA1682048, AAA1682049, AAA1682051, AAA1682052, AAA1682053, AAA1682054, AAA1692056, AAA1692057, AAA1692058, AAA1692059, AAA1692060, AAA1712011, AAA1712012, AAA1712013, AAA1712014, AAA1712015, AAA1712016, AAA1712017, AAA1722022, AAA1722023, AAA1722024, AAA1722036, AAA1722038, AAA1722039, AAA1722040, AAA1722041, AAA1722042, AAA1722043, AAA1722044, AAA1722045, AAA1732046, AAA1732047, AAA1732049.
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 77599This product is part of a recall event; the main page for the event is Xario 200 Tus-X200 diagnostic ultrasound system recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Xario 200 Tus-X200 diagnostic ultrasound system recalled | Toshiba American Medical Systems | Other | Nationwide | |
| CLASS II | Aplio 500 Tus-A500 diagnostic ultrasound system recalled | Toshiba American Medical Systems | Other | Nationwide | |
| CLASS II | Xario 100 Tus-X100 diagnostic ultrasound system recalled | Toshiba American Medical Systems | Other | Nationwide | |
| CLASS II | Aplio i-series: a) Aplio i700 Tus AI700 b) Aplio i800 Tus recalled | Toshiba American Medical Systems | Other | Nationwide |
More recalls from Toshiba American Medical Systems
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Diagnostic Ultrasound System, Aplio I-series recalled | Toshiba American Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Infx-8000V Fluoroscopic X-Ray Systems recalled | Toshiba American Medical Systems | Other | CA |
| Device | CLASS II | Infx-8000H Fluoroscopic X-Ray Systems recalled | Toshiba American Medical Systems | Other | CA |
| Device | CLASS II | Infx-8000F Fluoroscopic X-Ray Systems recalled | Toshiba American Medical Systems | Other | CA |
| Device | CLASS II | Infx-8000C Fluoroscopic X-Ray Systems recalled | Toshiba American Medical Systems | Other | CA |
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| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |