Butterfly iQ Ultrasound (2021-03-15)
- Starting date:
- March 15, 2021
- Posting date:
- April 1, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-75285
Last updated:
2021-04-16
Affected Products
- Butterfly IQ Ultrasound System (ultrasound transducer)
- Butterfly Network App
Reason
A discrepancy between a purchaser's assigned country organization ID (account) and ship to country was identified. Access to device modes, tools or features are controlled through the account. Affected accounts potentially had access to the Auto Bladder Volume Tool and Pulsed Wave Doppler mode, which are not authorized for use in Canada.
Affected products
A. Butterfly IQ Ultrasound System (ultrasound transducer)
Lot or serial number
- More than 10 numbers, contact manufacturer
Model or catalog number
- 850-20003
Companies
- Manufacturer
-
BUTTERFLY NETWORK
530 OLD WHITFIELD RD
GUILFORD
06437
Connecticut
UNITED STATES
B. Butterfly Network App
Lot or serial number
- More than 10 numbers, contact manufacturer
Model or catalog number
- 975-20003-00
Companies
- Manufacturer
-
BUTTERFLY NETWORK
530 OLD WHITFIELD RD
GUILFORD
06437
Connecticut
UNITED STATES