Z-1339-2013Class II

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

Name: Z-1339-2013 LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is...
Creator: Boston Scientific CRM Corp
Published: 2013-04-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2013-04-10 / Terminated / root cause: software

FDA source

Boston Scientific CRM Corp began a recall of LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a... on 2013-04-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1339-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-10
Posted: 2013-05-20
Terminated: 2013-11-26
Recalling firm: Boston Scientific Corporation
Product: LATITUDE Patient Management System, Model 6488, Version 7.3. 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.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
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.
Root cause tag: software
FDA root cause: Software change control
Action: 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.
Quantity in commerce: 1
Distribution: Nationwide Distribution including DC and PR
Product codes and lots: n/a

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1339-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1339-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-20

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)