Device product
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
Z-1511-2020
Product summary
- Event
- Event 85077
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 devices
- Official record key
device-enforcement:Z-1511-2020
Official wording
Reason: Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
Code information: Serial Numbers: 008885, 010823, 010615, 007886
Distribution pattern: US Nationwide distribution in the states of NC, TN, and MO.
Derived failure modes
-
Unknown
Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.