Z-0216-2007

Propaq LT vital signs monitor, Model 802LTRN

Name: Z-0216-2007 Propaq LT vital signs monitor, Model 802LTRN
Creator: Welch Allyn Protocol, Inc
Published: 2006-10-22
License: https://open.fda.gov/license/

Welch Allyn Protocol, Inc. / initiated 2006-10-22 / Terminated

FDA source

Welch Allyn Protocol, Inc began a recall of Propaq LT vital signs monitor, Model 802LTRN on 2006-10-22. The reason FDA records is "Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0216-2007
Status: Terminated
Initiated: 2006-10-22
Posted: 2006-11-28
Terminated: 2011-08-02
Recalling firm: Welch Allyn Protocol, Inc.
Product: Propaq LT vital signs monitor, Model 802LTRN
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT.
FDA 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 in commerce: total of both models 1031
Distribution: Devices were distributed to hospitals/medical centers and dealers worldwide.
Product codes and lots: KA001225 through KA002847

Product code MWI

K033378Class IIVital Signs Monitor, Propaq LtWelch Allyn Protocol, Inc. / cleared 2004-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)