SonarMed Inc: Medical Device Recall in 2019 - (Recall #: Z-2450-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

SonarMed AirWave Monitor, Model Number M0001

Product Classification:

Class II

Date Initiated: April 17, 2017

Date Posted: September 11, 2019

Recall Number: Z-2450-2019

Event ID: 82987

Reason for Recall:

Potential for the presence of two error codes which would make the monitor inoperable.

Status: Terminated

Product Quantity: 16 units

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

Voluntary or Mandated:

Voluntary: Firm initiated