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Recall Observatory FDA recall evidence

Device product

Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator

Z-2530-2023

July 26, 2023

Class I

Product summary

Firm
Hamilton Medical, Inc.
Event
Event 92873
Status
Ongoing
Classification
Class I
Quantity
4 shielding set
Official record key
device-enforcement:Z-2530-2023

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 / Affected Serial Numbers: 4050193, 4050210, 4050194 and 4016669

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.