Device recall: Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
Class II FDA enforcement event 66059. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Toshiba American Medical Systems Inc started this device recall on 5 Aug 2013. The firm address in the FDA record is in Tustin, CA. FDA put the recall in Class II. FDA event 66059 has 4 product records. The first FDA enforcement report date is 6 Nov 2013. The record gives the status Terminated, with the termination date 28 Jun 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Distribution including and US Territory Puerto Rico
Recalling firm
Toshiba American Medical Systems Inc, Tustin, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0119-2014 | Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging | 17 (1352 Total) | Class II | Terminated | 6 Nov 2013 |
| Z-0120-2014 | Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging | 477 (1352 total) | Class II | Terminated | 6 Nov 2013 |
| Z-0121-2014 | Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging | 427 units (1352 total) | Class II | Terminated | 6 Nov 2013 |
| Z-0122-2014 | Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging | 430 (1352 total) | Class II | Terminated | 6 Nov 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2013
- 1,236
- Share of these events in Class II
- 90%
- Product records in this event
- 4Median of the firm: 1
- Events of the firm on the register
- 36
Other events of the firm
Official channels
- FDA enforcement report Z-0119-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 66059. https://recallregister.com/fda/ii/66059/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Distribution including and US Territory Puerto Rico
- What quantity of product is in FDA event 66059?
- The event has 4 product records. The first record gives this quantity:
17 (1352 Total)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 90% of the 1,236 device events that started in 2013 are in Class II.