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Boston Scientific Corporation recalls Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is inte
Recalled October 3, 2018 · FDA recall Z-3260-2018 · Boston Scientific
Hazard
There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation. · FDA Class II
Units
74 units
Sold at
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
Description
There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
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.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →