FDA Medical Device Recalls (openFDA)
Respironics, Inc.: REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265
- Recall number
- Z-0447-2007
- Recalling firm
- Respironics, Inc.
- Product
- REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265
- Status
- Terminated
- Initiated
- 2006-10-25
- Posted
- 2007-01-10
- Terminated
- 2009-12-15
- Reason
- AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device
- Root cause
- Other
- Action
- 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.
- Quantity
- 235 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, Portugal, Saudia Arabia, Korea, Mexico, Finland, Taiwan, Philippines, Iceland, Brazil, Kuwait, New Zealand, Chile, India, Egypt, Norway, Turkey, Jordan, Thailand, Hungary, Russia, Peru, South Africia, Israel, Czech, Pakistan, Lebanon, Venezuela, Sweden, United Arab Emirates, Qatar, Slovakia, Bulgaria, Bermuda, and Colombia.
- Lot, serial or model codes
- Part number 1006265, Lot number 020613, 020614, 020801, 020823, 020926, 021121, 021226, 030130, 030303, 030320, 303401, 303417, 030423, 030514, and 030611.
- 510(k) numbers
- ["K010263"]
- PMA numbers
- not on file
- Product code
- BTT
- Firm FEI
- 2518422
- Firm city
- Murrysville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28