LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use

FDA device recall Z-1339-2013 · posted 2013-05-20 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

Reason for recall

Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended.

Action taken

Boston Scientific CRM Corp began re-faxing the 4,912 previously illegible PMR notifications on April 10, 2013 and completed on April 15, 2013, successfully fulfilling labeling expectations that these notifications be communicated to the clinic. For questions regarding this recall call 651-582-4000.

Root cause

Software change control

Status

Terminated

Product code

LWS

Quantity affected

1

Distribution

Nationwide Distribution including DC and PR

Date initiated

2013-04-10

Date posted

2013-05-20

Date terminated

2013-11-26

Location

Saint Paul, MN