Guidant LATITUDE Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The

FDA device recall Z-0180-2010 · posted 2009-11-12 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

Reason for recall

The L ATITUDE communicator (Model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor afer initial setup. The issue has been resolved. If any patient weight or blood pressure readings are stored in the patient's sensor, they will be uploaded to LATITUDE after the patient's communicator calls in to Boston Scientific's servers. It

Action taken

Boston Scientific used phone calls as the delivery method for these communications. The communication began August 6, 2009 for the original 6 patients affected. Notifications via phone calls to additional patients affected began on August 17, 2009. Direct questions about the recall to the LATITUDE Customer Service by calling 1-651-582-4000.

Root cause

Software design

Status

Terminated

Product code

LWS

Quantity affected

97

Distribution

Nationwide Distribution -- AZ, AR, CA, CT, FL, GA, IL, IN, MA, MO, NV, NJ, NY, OH, OR, PA, SC, TX, UT, VA and WA.

Date initiated

2009-08-07

Date posted

2009-11-12

Date terminated

2012-12-04

Location

Saint Paul, MN