HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Reported: August 31, 2022 Initiated: June 27, 2022 #Z-1525-2022
Product Description
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
Details
- Recalling Firm
- Hamilton Medical AG
- Units Affected
- 358
- Distribution
- US nationwide distribution including Puerto Rico.
- Location
- Bonaduz
Frequently Asked Questions
What product was recalled? ▼
HAMILTON-C6 Intensive Care Ventilator, REF: 160021. Recalled by Hamilton Medical AG. Units affected: 358.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2022. Severity: Critical. Recall number: Z-1525-2022.
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