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 Class 3 Recall
Boston Scientific, LATITUDE® Patient Management System Communicator		see related information
Date Posted September 28, 2011
Recall Number Z-3283-2011
Product Boston Scientific, LATITUDE® Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St Paul, MN 55112-5798 Boston Scientific, LATITUDE® RF Communicator & Software, Model 6482.Distributed by Boston Scientific, 4100 Hamline Avenue North, St Paul, MN 55112-5798 LATITUDE Communicator REF 6468 (only distributed outside the US) The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
Code Information MODEL SERIAL 6476 195543 6476 195544 6476 195550 6476 195555 6476 195556 6476 195557 6476 195560 6476 195562 6476 195563 6476 195566 6476 195701 6476 195707 6476 195708 6476 195711 6476 195713 6476 195717 6476 195722 6476 195725 6476 195726 6476 195727 6476 195728 6476 195729 6476 195733 6476 195734 6476 195735 6476 195736 6476 195739 6476 195740 6476 195742 6476 195744 6476 195748 6476 195749 6476 195751 6476 195764 6476 195765 6476 195767 6476 195768 6476 195769 6476 195770 6476 195773 6476 195775 6476 195776 6476 195780 6476 195783 6476 195786 6476 195797 6476 195800 6476 195803 6476 195867 6476 195870 6476 195872 6476 195876 6476 195909 6476 195910 6476 195911 6476 195914 6476 195915 6476 195916 6476 195919 6476 195922 6476 195923 6476 195924 6476 195928 6476 195929 6476 195930 6476 195934 6476 195938 6476 195977 6476 195980 6476 196034 6476 196052 6476 196083 6476 196086 6476 196167 6476 196170 6476 196171 6476 196172 6476 196173 6476 196174 6476 196177 6476 196181 6476 196183 6476 196184 6476 196187 6476 196188 6476 196189 6476 196192 6476 196194 6476 196196 6476 196220 6476 196223 6476 196228 6476 196231 6476 196237 6476 196238 6476 196240 6476 196244 6476 196247 6476 196253 6476 196256 6476 196270 6476 196295 6476 196307 6476 196347 6476 196350 6476 196353 6476 196354 6476 196356 6476 196361 6476 196365 6476 196368 6476 196369 6476 196371 6476 196375 6476 196376 6476 198243 6476 198293 6476 198304 6476 198485 6476 198487 6476 198502 6476 198512 6476 198515 6476 198516 6476 198873 6476 198881 6476 198888 6476 198890 6476 199443 6476 199444 6476 199446 6476 199447 6476 199448 6476 199449 6476 199450 6476 199451 6476 199452 6476 199453 6476 199454 6476 199455 6476 199456 6476 199457 6476 199458 6476 199459 6476 199460 6476 199464 6476 199465 6476 199467 6476 199468 6476 199470 6476 199471 6476 199473 6476 199474 6476 199476 6476 199485 6476 199488 6476 199489 6476 199491 6476 199501 6476 199503 6476 199504 6476 199507 6476 199508 6476 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199975 6476 199976 6476 199978 6476 199979 6476 199982 6476 199984 6476 199985 6476 199986 6476 199987 6476 199988 6476 199990 6476 199991 6476 199993 6476 199994 6476 199995 6476 199998 6476 200001 6476 200004 6476 200007 6476 200010 6476 200013 6476 200016 6476 200019 6476 200022 6482 045402 6482 045406 6482 045411 6482 045423 6482 045431 6482 045436 6482 045441
Recalling Firm/
Manufacturer		 Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul, Minnesota 55112-5700
Reason for
Recall		 A limited number of Model 6476, 6482, and 6468 (Not available in the US) LATITUDE Communicators are unable to authenticate, and thus cannot connect to the LATITUDE System. Customers are instead receiving Latitude Temporarily Unavailable (LTU) message.
Action Boston Scientific CRM Corporation sent a " Dear Patient", letter dated August 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A new communicator is being shipped separately to you with a corrected security certificate that will allow it to be activated and function normally. 1. Please activate this new equipment at your convenience to begin home monitoring. Activation instructions are enclosed with the communicator. 2. We also ask that you return the original communicator previously delivered to you: " Place the original equipment in the shipping box used for the new equipment. " Pack newspaper or other filler around the equipment to prevent damage during shipping, and seal the box. " Enter your address in the FROM section of the prepaid Federal Express label, and apply the return label to the outside of the box directly over the original label. " Call Federal Express at 1.800.463.3339 to schedule a pick-up. We apologize for this inconvenience. If you have further questions, please call 1.866.484.3268.
Quantity in Commerce 470
Distribution Worldwide Distribution -- (USA) nationwide including the states of AL, AK, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA,ME, MD, MA, MI, MN, MS, MO, MT, NE,NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY., and the countries of United Kingdom, France
 
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