Devices

Device Recall Renamic and ICS 3000

  • Model / Serial
    Affected Product Part Numbers: 394229, 400335, 403222, 406797, 408849
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • 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.
  • Manufacturer
    BIOTRONIK, Inc.
  • 1 Event

Manufacturer

BIOTRONIK, Inc.
  • Manufacturer Address
    BIOTRONIK, Inc., 6024 Jean Rd, Lake Oswego OR 97035-5571
  • Manufacturer Parent Company (2017)
    Micro Systems International Ag
  • Manufacturer comment
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    USFDA