Recall Z-1260-2009 ยท BZD Ventilator, Non-Continuous (Respirator)
Respironics
Remstar Pro M-Series Heated Humidifier System.
| Date | Jun 17, 2009 (initiated Feb 5, 2009) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| 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 service@respironics.com or clinical@respironics.com. |
| Quantity | 449,585 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072996 | REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM Respironics, Inc., Dec 27, 2007 |