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Aug 21

Respironics REMstar M Series Pro w/Integrated Humidifier RECALL 05 Feb 2009



PRODUCT
Remstar Pro M-Series CPAP and Heated Humidifier System. Catalog Numbers: 1049109, 1049110, 1049111, and AC1049109. Recall # Z-1260-2009

RECALLING FIRM/MANUFACTURER
Respironics, Monroeville, PA, by letter dated February 5, 2009. Firm initiated recall is ongoing.
REASON
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.
VOLUME OF PRODUCT IN COMMERCE
449,585 units
DISTRIBUTION
OR, OH, KY, TX, MO, AZ, IN and NV and countries of United Arab Emirates, Bosnia, Belgium, Bulgaria, Bahrain, Canada, Czech Republic, Denmark, Egypt, Spain, Finland, Greece, Croatia, Hungary, Ireland, Israel, Jordan, Kuwait, Lebanon, Latvia, Macedonia, Netherlands, Norway, Oman, Poland, Portugal, Romania, Qatar, Russia, Slovenia, Turkey, Serbia and South Africa

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=81028

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