Biotronik Recalls Unapproved Pacemaker Programmer Software Versions
Biotronik is recalling specific pacemaker programmer software versions because they are not approved for use in the United States.
- 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.
- Category
- Medical Device
- Distribution
- Distributed nationwide