The Recall Desk
SevereFDA (Devices)·Z-2529-2023·Announced 2023-09-27

Ventilator Control Board Spare Parts Recalled Due to Electrical Short-Circuit Risk

Hamilton Medical is recalling 6 control board spare parts for ventilators due to degrading capacitors that may leak electrolyte and cause electrical short circuits, potentially interrupting ventilation.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recalls carry a minimum severity of Severe (4). The hazard—capacitor electrolyte leakage causing electrical short circuits and potential ventilation interruption—poses a direct risk to ventilator-dependent patients, though no illnesses are reported in the source.

Plain-English summary

Hamilton Medical, Inc. is recalling 6 units of the Hamilton C1/T1/MR1 control board spare part (REF: MSP161502/12) due to a defect affecting ventilator functionality.

Capacitors on the control board may degrade and leak electrolyte, which can cause an electrical short circuit on the board. This can result in loss of capacitor function and potentially interrupt ventilation to patients.

The affected spare parts have serial numbers: 4001901, 4002139, 4003445, 4003567, 4003576, and 4005595. These units were distributed throughout the United States, including Puerto Rico.

Facilities using these spare parts should discontinue use and contact Hamilton Medical, Inc. for replacement or repair information.

The recalled product

Product
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
Manufacturer
Hamilton Medical, Inc.
Hazard
  • short-circuit
  • electrolyte-leak
  • ventilation-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • UDI: 07630002805247 / Affected Serial Numbers: 4001901
  • 4002139
  • 4003445
  • 4003567
  • 4003576
  • 4005595

Distribution

Distributed nationwide across the United States.