REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792,
FDA device recall Z-0446-2007 · posted 2007-01-10 · Terminated
Recall details
- Recalling firm
- Respironics, Inc.
- Reason for recall
- AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device
- Action taken
- The recalling firm issued a recall letter dated 10/25/06 to their domestic and Canadian dealers informing them of the problem and the need to contact the end users. These dealers were given two options: 1) contact the end user by forwarding a letter the recalling firm provided or 2) contacting the third party company with their distribution list. The recalling firm issued a recall letter dated 10/25/06 regarding the service repair kit and the need to contact end users that had the device repaired using this kit. The recalling firm issued a recall letter date 10/25/06 to the international customers informing them of the problem, contact the end users, and the need to destroy the recalled part.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTT
- Quantity affected
- 172,000 units
- Distribution
- Worldwide Distribution ---- including USA and countries of Denmark, Austria, France, Canada, Netherlands, Japan, Hong Kong, Austrailia, Great Britain, Spain, Belgium, Germany, Poland, Ireland, Portuga
- Date initiated
- 2006-10-25
- Date posted
- 2007-01-10
- Date terminated
- 2009-12-15
- Location
- Murrysville, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REMSTAR PLUS CPAP SYSTEM (K010263) | Respironics, Inc. | 2001-03-29 |