FDA Device recall Z-2376-2015
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software
- FDA Device
- Class II
- terminated
- Published 2015-08-19
On 2015-08-19 the FDA classified a Class II recall of PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software by Biotronik, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2376-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-30 |
| Published | 2015-08-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biotronik |
| Distribution | 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.
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.
Identifiers
| code_info | Affected Product Part Numbers: 394229, 400335, 403222, 406797, 408849 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2376-2015%22
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