FDAClass IIJuly 19, 2017

XARIO 200 TUS-X200 diagnostic ultrasound system recall

XARIO 200 TUS-X200 diagnostic ultrasound system

Why was XARIO 200 TUS-X200 diagnostic ultrasound system recalled?

When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Number W5B1712472

Product
XARIO 200 TUS-X200 diagnostic ultrasound system
Recalling firm
Toshiba American Medical Systems Inc
Quantity
1 unit
Distribution
Nationwide Distribution
Recall date
July 19, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls