The Recall Desk
Agency classClass IOur severity: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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.
Category
Medical Device — Ventilator / Respiratory Care
Hazard
Affected units
6

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Hamilton Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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