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U.S. Department of Health and Human Services

Class 2 Device Recall SonarMed AirWave Airway Monitoring System

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 Class 2 Device Recall SonarMed AirWave Airway Monitoring Systemsee related information
Date Initiated by FirmApril 17, 2017
Create DateSeptember 04, 2019
Recall Status1 Terminated 3 on July 16, 2020
Recall NumberZ-2450-2019
Recall Event ID 82987
510(K)NumberK143042 
Product Classification airway monitoring system - Product Code OQU
ProductSonarMed AirWave Monitor, Model Number M0001
Code Information UDI Numbers: (01)00851334007001(11)130426(21)339 (01)00851334007001(11)130502(21)342 (01)00851334007001(11)131105(21)365 (01)00851334007001(11)140522(21)369 (01)00851334007001(11)140522(21)373 (01)00851334007001(11)150609(21)379 (01)00851334007001(11)150609(21)381 (01)00851334007001(11)150609(21)382 (01)00851334007001(11)150630(21)383 (01)00851334007001(11)150630(21)385 (01)00851334007001(11)150630(21)386 (01)00851334007001(11)150630(21)388 (01)00851334007001(11)150630(21)389 (01)00851334007001(11)150630(21)390 (01)00851334007001(11)150701(21)391 (01)00851334007001(11)150701(21)393
Recalling Firm/
Manufacturer		 SonarMed Inc
12220 N Meridian St Ste 150
Carmel IN 46032-6972
For Additional Information Contact
317-489-3161
Manufacturer Reason
for Recall		Potential for the presence of two error codes which would make the monitor inoperable.
FDA Determined
Cause 2		Software design
ActionApril 2017, firm notifications were made in person at the time of the visit to upgrade the firmware. All monitors that had not been distributed were upgraded to the new firmware. All subsequent shipments will have the updated firmware.
Quantity in Commerce16 units
DistributionCA & TX
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OQU
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