Recall Z-3260-2018— Boston Scientific Corporation
Class II · Terminated
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2018-09-10, terminated 2021-09-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Model 3300 LATITUDE(TM) Programming System 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.. Reason: There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-10
- Terminated
- 2021-09-22
- Firm location
- Saint Paul, MN, United States
Product description
Model 3300 LATITUDE(TM) Programming System 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.
Reason for recall
There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.