Boston Scientific, LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 H

FDA device recall Z-3283-2011 · posted 2011-09-28 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

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 taken

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.

Root cause

Other

Status

Terminated

Product code

LWS

Quantity affected

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,

Date initiated

2011-08-01

Date posted

2011-09-28

Date terminated

2012-11-06

Location

Saint Paul, MN