FDA recall Z-1525-2022

Product

HAMILTON-C6 Intensive Care Ventilator, REF: 160021

Reason for recall

Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multiple technical faults in a short time may force ventilators into Safety Ventilation (blower runs constantly) or Ambient Sate (inspiratory channel/expiratory valves opened; patient breaths room air unassisted) with Panel connection lost message displayed

Distribution

US nationwide distribution including Puerto Rico.

Key facts

Status

Ongoing

Initiation date

2022-06-27

Report date

2022-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bonaduz, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1525-2022