BIOTRONIK, Inc. recalls PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for u

Recalled August 19, 2015 · FDA recall Z-2376-2015 · BIOTRONIK

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. · FDA Class II

Units

768 units (software)

Sold at

Nationwide Distribution.

Description

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.

Product

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.

Manufacturer(s)

BIOTRONIK, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →