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Recall Observatory FDA recall evidence

Device product

Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.

Z-2057-2015

March 24, 2015

Class II

Product summary

Firm
Hamilton Medical, Inc.
Event
Event 71234
Status
Terminated
Classification
Class II
Quantity
248
Official record key
device-enforcement:Z-2057-2015

Official wording

Reason: Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.

Code information: Software version 2.20 and 2.41,

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.