FDA Medical Device Recalls (openFDA)
Respironics: Remstar Pro M-Series Heated Humidifier System.
- Recall number
- Z-1260-2009
- Recalling firm
- Respironics
- Product
- Remstar Pro M-Series Heated Humidifier System.
- Status
- Terminated
- Initiated
- 2009-02-05
- Posted
- 2009-06-17
- Terminated
- 2012-07-05
- 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, Netherlands, Norway, Oman, Poland, Portugal, Romania, Qatar, Russia, Slovenia, Turkey, Serbia and South Africa.
- Lot, serial or model codes
- Catalog Numbers: 1049109, 1049110, 1049111, and AC1049109.
- 510(k) numbers
- ["K072996"]
- PMA numbers
- not on file
- Product code
- BZD
- Firm FEI
- 3007871739
- Firm city
- Monroeville
- 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