Class 2 Device Recall Propaq LT vital signs monitor

• Date Initiated by Firm: October 22, 2006
• Date Posted: November 28, 2006
• Recall Status: Terminated on August 02, 2011
• Recall Number: Z-0216-2007
• Recall Event ID: 36628
• 510(K)Number: K033378
• Product Classification: vital signs monitor - Product Code MWI
• Product: Propaq LT vital signs monitor, Model 802LTRN
• Code Information: KA001225 through KA002847
• Recalling Firm/ Manufacturer: Welch Allyn Protocol, Inc; 8500 Sw Creekside Pl; Beaverton OR 97008
• For Additional Information Contact: Jeff Wagner; 503-530-7909
• Manufacturer Reason for Recall: Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MWI