Remstar Pro M-Series Heated Humidifier System.
FDA Recall Z-1260-2009 · Posted 2009-06-17
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Recalling FirmRespironics
Recall StatusTerminated
Product CodeBZD
Date Initiated2009-02-05
Date Terminated2012-07-05
Product Quantity449,585 units
Reason for Recall
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.
Firm Action
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 [email protected] or [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution -- US including states of 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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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