Remstar Pro M-Series Heated Humidifier System.
FDA device recall Z-1260-2009 · posted 2009-06-17 · Terminated
Recall details
- Recalling firm
- Respironics
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- BZD
- Quantity affected
- 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, Sp
- Date initiated
- 2009-02-05
- Date posted
- 2009-06-17
- Date terminated
- 2012-07-05
- Location
- Monroeville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM (K072996) | Respironics, Inc. | 2007-12-27 |