Reported Aug 31, 2022 · Ongoing
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Hamilton Medical AG
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hamilton Medical AG · Via Crusch 8 · Bonaduz · N/A
Is this the product you have?
- HAMILTON-C6 Intensive Care Ventilator
- REF160021
- Lot codes and dates
- UDI-DI07630002808590
- Serial Numbers
358 of 358 codes
566369956907695271777772693261578658730759396858623186206349835664808322830691009101909990986219789478618003672378024833726579807666738267747358771968966925907390629298929493019292929392909300929992919231913291088310860482558599715683138344
- Amount recalled
- 358
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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