Z-2450-2019 Class II Terminated

Recalled by SonarMed Inc — Carmel, IN

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