Device product
SonarMed AirWave Monitor, Model Number M0001
Z-2450-2019
Product summary
- Firm
- SonarMed Inc
- Event
- Event 82987
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 units
- Official record key
device-enforcement:Z-2450-2019
Official wording
Reason: Potential for the presence of two error codes which would make the monitor inoperable.
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
Distribution pattern: CA & TX
Derived failure modes
-
Unknown
Potential for the presence of two error codes which would make the monitor inoperable.