Company: BIOTRONIK Inc..
Date of Enforcement Report 8/19/2015
Class lI:
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. Recall Number Z-2376-2015
REASON
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.
RECALLING FIRM/MANUFACTURER
BIOTRONIK, Inc., Lake Oswego, OR on 6/30/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
768 units (software)
DISTRIBUTION
Nationwide
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