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.
Recall
- Recall Number
- Z-3260-2018
- Event Number
- 81006
- Firm
- Boston Scientific Corporation
- FEI Number
- 2124215
- Product Code
- LWS
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- September 10, 2018
- Terminated
- September 22, 2021
- Address
- 4100 Hamline Ave N, Bldg 3, Saint Paul, MN, 55112-5700
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.
There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
The firm initiated the recall on 09/10/2018 to the US sales representatives by email. The sales representatives were asked to hand deliver the notice to the hospitals when the programmer is retrieved for that location. The sales representatives will electronically confirm the hand delivery of the letter to each affected customer after it occurs.
Worldwide distribution - US Nationwide in the State of FL, UT, and VA, and countries of Austria, Czech Republic, Germany, Greece, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, Switzerland
74 units