CLASS II Device recall · Reported 6 Nov 2013 · FDA Enforcement Report
Xario Diagnostic Ultrasound System SSA-660A Used recalled
Toshiba American Medical Systems is recalling Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging, distributed nationwide in the US. The recall was initiated on 5 Aug 2013 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-0119-2014
- FDA event ID
- 66059
- Recalling firm
- Toshiba American Medical Systems, Tustin, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Aug 2013
- FDA classified
- 30 Oct 2013
- Reported
- 6 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Imaging Equipment
Timeline
| 5 Aug 2013 | Recall initiated by company | |
| 30 Oct 2013 | Classified by FDA | +86 days |
| 6 Nov 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
Where it was distributed
Nationwide Distribution including and US Territory Puerto Rico
Questions about this recall
Why was it recalled?
The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly
Which lots are affected?
Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA0792617 LGA0792554 LGA0792626 LGA0792627 LGA0792552 LGA0792616 LGA0792563 LGA0792553 LGA0792615 LGA0792551 LGA0792613
Where was it sold?
Nationwide Distribution including and US Territory Puerto Rico
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
3 other products · FDA event 66059This product is part of a recall event; the main page for the event is Aplio MX Diagnostic Ultrasound System SSA-780A Used recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Aplio MX Diagnostic Ultrasound System SSA-780A Used recalled | Toshiba American Medical Systems | Temperature Abuse | Nationwide | |
| CLASS II | Aplio XG Diagnostic Ultrasound System SSA-790A Used recalled | Toshiba American Medical Systems | Temperature Abuse | Nationwide | |
| CLASS II | Xario XG Diagnostic Ultrasound System SSA-680A Used recalled | Toshiba American Medical Systems | Temperature Abuse | 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 |