Hamilton C6 ventilators recalled over circuit board defect interrupting ventilation
Hamilton C6 ventilators are recalled over a mechanical defect on a printed circuit board that may cause the device to fail at startup or interrupt ventilation during use. 1,040 systems are affected.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this ventilator defect as Class I.
Plain-English summary
The Hamilton C6 ventilator, REF 160021, with ESM board part number 10144626, GTIN 07630002808590 and UDI-DI 76300028PN160021ZW, is being recalled. The Hamilton C6 provides positive pressure ventilatory support to adults and paediatric patients and optionally to infants and neonates. The recall covers 1,040 systems distributed nationwide in the United States.
The recall was issued because of a mechanical defect on a printed circuit board arising from the board separating process. The defect might cause the ventilator either to fail at startup, with no patient involvement, or to enter ambient state during use, resulting in an interruption of ventilation. The FDA classified the action as Class I, its most serious category.
Hospitals operating affected ventilators should check the model and board part numbers against the recall notice and follow the manufacturer's instructions for correction or replacement.
The recalled product
- Product
- Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
- Manufacturer
- Hamilton Medical AG
- Category
- Medical Device — Ventilator
- Affected units
- 1,040
Distribution
Distributed nationwide across the United States.
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