Z-2450-2019 Class II Terminated
FDA device recall Z-2450-2019 was initiated by SonarMed Inc on April 17, 2017 and is designated Class II. Reason for recall: Potential for the presence of two error codes which would make the monitor inoperable. The recall status is terminated (terminated July 16, 2020). Affected quantity: 16 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2019
- Initiation Date
- April 17, 2017
- Termination Date
- July 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units
Product Description
SonarMed AirWave Monitor, Model Number M0001
Reason for Recall
Potential for the presence of two error codes which would make the monitor inoperable.
Distribution Pattern
CA & TX
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