FDA Medical Device Recalls (openFDA)
Compumedics Usa, Ltd: Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia
- Recall number
- Z-0652-05
- Recalling firm
- Compumedics Usa, Ltd
- Product
- Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia
- Status
- Terminated
- Initiated
- 2005-02-24
- Posted
- 2005-03-24
- Terminated
- 2007-12-07
- Reason
- Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin.
- Root cause
- Other
- Action
- The firm initiated the recall on February 24, 2005 via letter with return response post card.
- Quantity
- 1376 units
- Distribution
- Product was distributed nationwide and to the following foreign countries: Australia, Canada, Greece, Hong Kong, Hungary, India, Iran, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pillippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, and the United Kingdom.
- Lot, serial or model codes
- All codes
- 510(k) numbers
- ["K000068"]
- PMA numbers
- not on file
- Product code
- GWQ
- Firm FEI
- 3002716534
- Firm city
- El Paso
- Firm state
- TX
- 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