Skip to content
Recall Observatory FDA recall evidence

Device product

Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.

Z-1104-2013

December 11, 2012

Class II

Product summary

Firm
Toshiba American Medical Systems Inc
Event
Event 64693
Status
Terminated
Classification
Class II
Quantity
233 units
Official record key
device-enforcement:Z-1104-2013

Official wording

Reason: Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. The startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. It has been determined that this may potentially cause damage to the system.

Code information: Item numbers: TUS-A300/Wl and TUS-A500/Wl

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. The startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. It has been determined that this may potentially cause damage to the system.