FDA Device

Remstar Pro M-Series Heated Humidifier System.

Hazard

Malfunction of the J3 connection between the Heater Plate Main printed circuit assembly (PCA) and the heater plate may have an intermittent connection which may lead to excessive heat build-up on the humidifier PCA.

What You Should Do

Remedy

A Service Communication dated February 5, 2009 was provided to all Respironics customers that are approved to service Respironics devices. The communication described the affected device and actions required. Further questions may be addressed by phone at 1-800-345-6443, and by email at service@respironics.com or clinical@respironics.com.

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Products

Remstar Pro M-Series Heated Humidifier System.
Brand
Respironics
UPC
Catalog Numbers: 1049109, 1049110, 1049111, and AC1049109.

Units Affected

449,585 units

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