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U.S. Department of Health and Human Services

Class 2 Device Recall REMStar Mseries Heated Humidifier System

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 Class 2 Device Recall REMStar Mseries Heated Humidifier Systemsee related information
Date Initiated by FirmFebruary 05, 2009
Date PostedJune 17, 2009
Recall Status1 Terminated 3 on July 05, 2012
Recall NumberZ-1260-2009
Recall Event ID 51699
510(K)NumberK072996 
Product Classification Ventilator, non-continuous (respirator) - Product Code BZD
ProductRemstar Pro M-Series Heated Humidifier System.
Code Information Catalog Numbers: 1049109, 1049110, 1049111, and AC1049109.
FEI Number 3007871739
Recalling Firm/
Manufacturer		 Respironics
1740 Golden Mile Hwy
Monroeville PA 151462012
For Additional Information ContactKatherine dePauda
724-387-7770
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionA 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.
Quantity in Commerce449,585 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BZD
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