FDAClass IIJuly 19, 2023

GE Healthcare Vivid S60 recall

GE Healthcare Vivid S60, ultrasound device

Why was GE Healthcare Vivid S60 recalled?

GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Software versions: v203, v204

Product
GE Healthcare Vivid S60, ultrasound device
Recalling firm
GE Vingmed Ultrasound As
Quantity
2 units
Distribution
Worldwide distribution.
Recall date
July 19, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls