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Recall Observatory FDA recall evidence

Device product

Hamilton-MR1, REF: 161010, Intensive Care Ventilator

Z-2528-2023

July 26, 2023

Class I

Product summary

Firm
Hamilton Medical, Inc.
Event
Event 92873
Status
Ongoing
Classification
Class I
Quantity
12 units
Official record key
device-enforcement:Z-2528-2023

Official wording

Reason: Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

Code information: UDI: 07630002800761 & 07630002813556 / Affected Serial Numbers: 3422 3423 3424 3425 3426 3427 3428 3429 3469 3503 3510 3800

Distribution pattern: Distribution US nationwide, including Puerto Rico. OUS: Not provided

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.