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St Jude Medical Inc. recalls PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generato
Recalled October 25, 2017 · FDA recall Z-0035-2018 · St Jude Medical
Hazard
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. · FDA Class II
Units
101 units
Sold at
Worldwide Distribution
Description
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Product
PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
Manufacturer(s)
St Jude Medical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →