Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0215-2007

Propaq LT vital signs monitor, Model 802LTON

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

Welch Allyn Protocol, Inc began a recall of Propaq LT vital signs monitor, Model 802LTON on . 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 , the recall status on record is Terminated.

Recall record

Recall number
Z-0215-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Welch Allyn Protocol, Inc.
Product
Propaq LT vital signs monitor, Model 802LTON
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