RecallRadar

FDA Device recall Z-0119-2014

Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging

On 2013-11-06 the FDA classified a Class II recall of Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging by Toshiba American Medical Systems, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0119-2014
ClassificationClass II
Statusterminated
Initiated2013-08-05
Published2013-11-06
Last updated2026-09-13 11:53 UTC
CompanyToshiba American Medical Systems
DistributionUS

Product

Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging

Reason

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

Identifiers

code_info
Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA…Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA0792617 LGA0792554 LGA0792626 LGA0792627 LGA0792552 LGA0792616 LGA0792563 LGA0792553 LGA0792615 LGA0792551 LGA0792613

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0119-2014%22

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