FDA-Device2015-08-19Class II
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.
BIOTRONIK, Inc.
Hazard
Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.
Sold states
Nationwide Distribution.
Affected count
768 units (software)
Manufactured in
6024 Jean Rd, N/A, Lake Oswego, OR, United States
Products
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2376-2015Don't want to check this manually?
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