SonarMed AirWave Monitor, Model Number M0001
This recall has been terminated (originally issued April 17, 2017).
- Company
- Sonarmed Inc
- Recall Initiated
- April 17, 2017
- Terminated
- July 16, 2020
- Recall Number
- Z-2450-2019
- Quantity
- 16 units
- Firm Location
- Carmel, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for the presence of two error codes which would make the monitor inoperable.
Distribution
CA & TX
Lot / Code Info
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
Root Cause
Software design
Action Taken
April 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.