FDA Medical Device Recalls (openFDA)
Masimo Corporation: Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
- Recall number
- Z-1187-2013
- Recalling firm
- Masimo Corporation
- Product
- Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
- Status
- Terminated
- Initiated
- 2013-03-13
- Posted
- 2013-04-29
- Terminated
- 2015-06-10
- Reason
- Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.
- Root cause
- Device Design
- Action
- Masimo Corporation sent an Urgent Recall Notification letter dated March 8, 2013, to all affected customers The letter identified the product the problem and the action needed to be taken by the customer. 1.Customers were instructed to please promptly remove all Rad-8 device(s) from use and your inventory and segregate these devices. 2. Please call 1-800-326-4890 and select option 2 for Technical Services. Determine with Technical Services whether you will return the affected device(s) to Masimo for repair or if eligible, receive a repair kit. If you will return the device(s) for repair, obtain a Return Material Authorization Number (RMA number). 3. Complete the Tracking/Verification Form in Attachment 2 and fax it to Masimo at 1-949-297-7700, even if you do not have or intend to use the affected device(s). 4. If you are eligible and intend to repair units onsite fax the completed original form in Attachment 2 to Masimo at 1-949-297-7700. 5. If you have elected to return the affected device(s), and have an RMA number include the completed original Form in Attachment 2 with the returned device(s) and indicate the RMA number on the outside of the return-shipping box. We apologize for the inconvenience. Please be assured that Masimo is committed to consistently providing high quality products and services to you, our customers. We thank you for your patience and cooperation while we actively work to resolve this issue. . .
- Quantity
- 42,908 units
- Distribution
- Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.
- Lot, serial or model codes
- Catalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194
- 510(k) numbers
- not on file
- 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