Reported Nov 6, 2013 · Terminated
Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging
Toshiba American Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Toshiba American Medical Systems Inc · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging
- Lot codes and dates
- Lot Numbers not utilized
- Serial Numbers
477 of 477 codes
99A07Y215199E099343799K128504499F103385799F103385899F103385999K11Z490699K11Z490799J111444599G109419499H10X424099E097330199G107405099G107405199G107405299E097330299J111444399G108411899D089268499K118480499D08Y274499K128503999K11Z491799E096314199E096315799E096315899E096316899D089268099D089268799D08Z284099D095312299E097330899E09X346399F09Z368499D08Z282999E099340899K128504199D089269299A07Y210999E099341499E099341599K121494099E098336999D089268899D089268999D089269199D089269399C087255299C087256899A07Y209799A07Y209899B07Z224899E099343699E099344599K123498599D095312599K118480599K128504699K12X505099K12X5051
- Amount recalled
- 477 (1352 total)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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