FDA Medical Device Recalls (openFDA)
Welch Allyn Protocol, Inc: Propaq LT vital signs monitor, Model 802LTON
- Recall number
- Z-0215-2007
- Recalling firm
- Welch Allyn Protocol, Inc
- Product
- Propaq LT vital signs monitor, Model 802LTON
- Status
- Terminated
- Initiated
- 2006-10-22
- Posted
- 2006-11-28
- Terminated
- 2011-08-02
- Reason
- Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT.
- Root cause
- Other
- Action
- A letter dated October 22, 2006 was sent to customers between October 25-27,2006. The letter advised of the problem and requested the customer contact the firm to arrange for return of the monitor to be serviced. The customer will be provided with a temporary replacement. The dealers were requested to notify their customers.
- Quantity
- total of both models 1031
- Distribution
- Devices were distributed to hospitals/medical centers and dealers worldwide.
- Lot, serial or model codes
- KA001225 through KA002847
- 510(k) numbers
- ["K033378"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 3023750
- Firm city
- Beaverton
- Firm state
- OR
- 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