SonarMed Inc: SonarMed AirWave Monitor, Model Number M0001

Is my product affected?

SonarMed AirWave Monitor, Model Number M0001

• UPC 00851334007001

Check against the official notice below — it lists the full affected range.

What happened

SonarMed Inc. is recalling the SonarMed AirWave Monitor, Model Number M0001, due to a potential for two error codes that could render the monitor inoperable. The recall affects 16 units distributed in California and Texas. The affected devices are identified by specific UDI numbers with manufacturing dates ranging from April 2013 to July 2015.

The record does not specify a remedy for consumers who possess affected units.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Potential for the presence of two error codes which would make the monitor inoperable. Distribution: CA & TX Quantity: 16 units 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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