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U.S. Department of Health and Human Services

Class 2 Device Recall Propaq LT vital signs monitor

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  Class 2 Device Recall Propaq LT vital signs monitor see related information
Date Initiated by Firm October 22, 2006
Date Posted November 28, 2006
Recall Status1 Terminated 3 on August 02, 2011
Recall Number Z-0215-2007
Recall Event ID 36628
510(K)Number K033378  
Product Classification vital signs monitor - Product Code MWI
Product Propaq LT vital signs monitor, Model 802LTON
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 2		 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 and Original Applicant = WELCH ALLYN PROTOCOL, INC.
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