FDA Medical Device Recalls (openFDA)
Masimo Corporation: Radical Handheld Pulse Oximeter
- Recall number
- Z-0933-05
- Recalling firm
- Masimo Corporation
- Product
- Radical Handheld Pulse Oximeter
- Status
- Terminated
- Initiated
- 2005-06-10
- Posted
- 2005-06-25
- Terminated
- 2008-06-17
- Reason
- Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.
- Root cause
- Other
- Action
- Recall was by letter to all customers who received units made before 12/11/01. They are to return for repair or have them fixed by an Authorized Masimo Service Representative.
- Quantity
- 8,110
- Distribution
- Nationwide and Korea, Hong Kong, Canada, New Zealand, Thailand, Argentina, Portugal, Malaysia, Ireland, Australia, japan, France, El Salvador, South Africa, UAE-Saudi Arabia, Germany, Mexico, Unitied Kingdom, Singapore, Germany, Kuwait, Chile, Spain, Iceland, Italy, Poland, Sweden, Norway, Venezuela, Lithuania, Czech Republic, Belgium, Neterlands, Austria, Switzerland, Egypt, Greece, France Taiwan.
- Lot, serial or model codes
- Serial numbers-- P3027 through P3148 and serial numbers less than or equal to 102999.
- 510(k) numbers
- ["K992340"]
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 3001452206
- Firm city
- Irvine
- 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