LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate wi
FDA device recall Z-1096-2012 · posted 2012-02-23 · Terminated
Recall details
- Recalling firm
- Boston Scientific CRM Corp
- Reason for recall
- Boston Scientific is conducting a recall involving the LATITUDE Patient Management System - Model 6488, software version 7.2 because patients are not able to perform setup. There is no risk to health associated with this issue.
- Action taken
- Beginning on December 19, 2011, for the patients that have attempted to set-up their communicators, Boston Scientific called the patients and their associated LATITUDE clinics to let them know that they can now complete the set-up.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LWS
- Quantity affected
- 1
- Distribution
- Nationwide Distribution, USA - including the states CA, MA, MI, NC, OK, PA, RI, TX, and WA.
- Date initiated
- 2011-12-19
- Date posted
- 2012-02-23
- Date terminated
- 2012-10-25
- Location
- Saint Paul, MN
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