FDA Medical Device Recalls (openFDA)
Resmed Corporation: ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following model names and product codes: S8 AUTOSET VANTAGE, #33112; S8 COMPACT, #33030; S8 ELITE, #33021; S8 ESCAPE, #33007.
- Recall number
- Z-1006-2007
- Recalling firm
- Resmed Corporation
- Product
- ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following model names and product codes: S8 AUTOSET VANTAGE, #33112; S8 COMPACT, #33030; S8 ELITE, #33021; S8 ESCAPE, #33007.
- Status
- Terminated
- Initiated
- 2007-04-23
- Posted
- 2007-07-03
- Terminated
- 2010-12-06
- Reason
- S8 devices manufactured between July 2004 and May 15, 2006 are susceptible to fatigue in the connection of the AC appliance inlet connector and the power supply (power cord) leading to possible failure (short circuit, electrical failure, sparks, smoke).
- Root cause
- Other
- Action
- ResMed began to broadly distribute information regarding the recall on 4/23/2007. A press release was issued on 4/23/2007 with information regarding the recall and information was posted at ww.resmed.com/s8program. The firm is providing a Consignee notification package and press release to include(1) specific device names subject to the recall and affected serial numbers; specific information to be provided in each package to the end-customer. The specific information to the end user customers will include: (1) specific device names subject to the recall; (2) affected serial numbers; (3)continuing use and safety information; and (4) contact information for requesting additional details. Patients are advised that they may continue to use their S8 flow generators until a replacement unit is provided. ResMed is instructing patients, sleep labs, and hospitals to continue using the device, placing it on a hard clean surface, with a clear area around the device. ResMed intends to replace the affected products with either a new device or a device in which the affected components have been replaced.
- Quantity
- 300,000
- Distribution
- Worldwide, USA, Canada, and Mexico.
- Lot, serial or model codes
- Serial numbers for all S8 models: From 20040285613 to 20060269563; From 20060275728 to 20060276751; From 20060277160 to 20060277415; From 20060281672 to 20060281991; From 20060283424 to 20060283743; From 20060284896 to 20060285445; From 20060287568 to 20060290823; From 20060292360 to 20060294694; From 20060312361 to 20060312597; From 20060318692 to 20060319459; From 20060325074 to 20060327794; From 20060330588 to 20060331043.
- 510(k) numbers
- ["K033841","K041209"]
- PMA numbers
- not on file
- Product code
- BZD
- Firm FEI
- 1000115734
- Firm city
- Poway
- Firm state
- CA
- 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