LATITUDE¿ Patient Management System — Class II medical device recall Z-1339-2013
Terminated recall by Boston Scientific CRM Corp, reported 2013-05-29, distributed nationwide. Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3
| Recall number | Z-1339-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific CRM Corp, Saint Paul, MN, United States |
| Recall initiated | 2013-04-10 |
| Classified | 2013-05-20 |
| Reported by FDA | 2013-05-29 |
| Terminated | 2013-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| Model numbers | 6488 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1339-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.