Recall Z-2376-2015— BIOTRONIK, Inc.
Class II · Terminated
Class II FDA medical device recall by BIOTRONIK, Inc., initiated 2015-06-30, terminated 2015-12-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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
- BIOTRONIK, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-30
- Terminated
- 2015-12-24
- Firm location
- Lake Oswego, OR, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.