FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance
[RECALL]Feb 24, 2020 · Butterfly Network · Butterfly iQ+ · South Africa
Failure Mode
RECALL
Event Date
Feb 24, 2020
Primary Entity
Butterfly Network
Robotic Platform
Butterfly iQ+
Jurisdiction / Location
South Africa
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Butterfly Network issued a correction notification after distributing the Auto Bladder Volume Tool without an approved 510(k). The action affected 15,121 host devices in US distribution. Butterfly disabled the tool via software update and removed marketing references.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=180229
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=180229
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Details
Incident Context & FAQ
What happened in FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance?
Butterfly Network issued a correction notification after distributing the Auto Bladder Volume Tool without an approved 510(k). The action affected 15,121 host devices in US distribution. Butterfly disabled the tool via software update and removed marketing references.
When did this incident occur?
The incident is recorded as occurring on February 24, 2020 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance?
Butterfly iQ+ by Butterfly Network is the recorded robot involved in this incident at South Africa.
Has anyone responded to FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.