The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2530-2023·Announced 2023-09-27

Ventilator Spare Parts Recalled for Degrading Capacitor Risk

Hamilton Medical is recalling ventilator spare parts (ESM Shielding Set) due to potentially degrading capacitors on the control board. These capacitors may leak electrolyte and cause a short circuit, 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 classification mandates a minimum severity score of 4. The affected component is part of a life-critical device (ventilator) where malfunction could interrupt ventilation, potentially causing serious patient harm. No illnesses or deaths have been reported to date.

Plain-English summary

Hamilton Medical, Inc. is recalling the Hamilton-T1 ESM Shielding Set, a spare part for ventilators. The recalled units have Universal Device Identification (UDI) 07630002800761 and specific serial numbers: 4050193, 4050210, 4050194, and 4016669.

The control board in the affected spare parts contains capacitors that may degrade over time. When capacitors degrade, they may leak electrolyte onto the control board. This leakage can cause an electrical short circuit or cause the capacitor itself to lose function.

If a short circuit or capacitor malfunction occurs, the ventilator may experience an interruption of ventilation. This can be life-threatening for patients who depend on mechanical ventilation. The affected spare parts were distributed nationwide in the United States, including Puerto Rico.

Patients and healthcare providers who use or maintain affected Hamilton-T1 ventilators should contact Hamilton Medical for further instructions. The FDA has classified this as a Class I recall, indicating that the issue poses a serious risk of harm.

The recalled product

Product
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
Manufacturer
Hamilton Medical, Inc.
Category
Medical Device — Ventilator Spare Parts
Hazard
Affected units
4

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 (3)

  • UDI: 07630002800761 / Affected Serial Numbers: 4050193
  • 4050210
  • 4050194 and 4016669

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 →

Related recalls

Same manufacturer · Hamilton Medical, Inc.

See all →

Similar recalls