The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2525-2023·Announced 2023-09-27

Portable Intensive Care Ventilator Recalled for Degrading Capacitor Issue

Hamilton Medical is recalling 164 Hamilton-C1 portable ventilators due to degrading capacitors that may leak electrolyte, causing electrical short circuits that could interrupt 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: This is an FDA Class I medical device recall. Although no illnesses or injuries have been reported, the defect directly affects a critical life-support function (ventilation), placing dependent patients at significant risk. FDA Class I classification establishes the minimum severity level at 4.

Plain-English summary

Hamilton Medical is recalling 164 Hamilton-C1 Portable Intensive Care Ventilators (REF: 161001) distributed nationwide in the United States, including Puerto Rico. The ventilators are affected by a control board capacitor degradation defect.

The capacitors on the control board may degrade over time, causing them to leak electrolyte onto the board. This electrolyte can cause electrical short circuits on the control board and loss of capacitor function, potentially interrupting ventilation to the patient.

Patients relying on affected ventilators and healthcare facilities should immediately verify whether their devices are included in this recall using the affected serial numbers provided by Hamilton Medical and the FDA. If a device is affected, contact Hamilton Medical for replacement or repair options. Do not continue using the ventilator if you suspect it is part of this recall.

This is FDA Class I medical device recall Z-2525-2023. Additional information is available from the FDA's Center for Devices and Radiological Health.

The recalled product

Product
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
Manufacturer
Hamilton Medical, Inc.
Category
Medical Device — Respiratory Equipment
Hazard
Affected units
164

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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