Reported Apr 24, 2024 · Ongoing
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
SonarMed Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SonarMed Inc · 12220 N Meridian St Ste 150 · Carmel, IN · 46032-6972
Is this the product you have?
- AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
- Lot codes and dates
- Model No. AW-M0001
- GTIN
146 of 146 codes
00851334007001Serial No. AW0572AW0573AW0574AW0577AW0578AW0579AW0580AW0581AW0584AW0585AW0586AW0588AW0591AW0593AW0594AW0600AW0606AW0607AW0615AW0616AW0624AW0626AW0627AW0648AW0650AW0651AW0658AW0664AW0672AW0674AW0675AW0678AW0680AW0681AW0684AW0685AW0701AW0702AW0703AW0704AW0705AW0706AW0707AW0708AW0709AW0710AW0711AW0712AW0718AW0719AW0720AW0721AW0722AW0723AW0724AW0725AW0726AW0727AW0728
- Amount recalled
- 145 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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