Butterfly iQ Ultrasound System Auto Bladder Volume recall
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software…
Why was Butterfly iQ Ultrasound System Auto Bladder Volume recalled?
Distributed without an approved 510(k)
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?
Software versions 1.13.0, 1.14.0, and 1.15.0 UDI: (01)00866646000206
- Product
- Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software…
- Recalling firm
- Butterfly Network, Inc.
- Quantity
- 15,121 host devices
- Distribution
- US Nationwide distribution.
- Recall date
- April 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)