Hamilton T1 Ventilator Recall for Pediatric Software Calculation Error
Hamilton Medical Inc is recalling 97 Hamilton T1 ventilators with software versions 1.1.2 or lower due to a calculation error affecting oxygen consumption estimates for small pediatric patients.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower…"
Plain-English summary
Hamilton Medical Inc is recalling 97 Hamilton T1 ventilators equipped with software versions 1.1.2 or lower. The affected units include 69 ventilators of part number 161005 and 28 of part number 161006. These devices are intended to provide positive pressure ventilatory support to adults and pediatrics.
The recall was initiated after an analysis of a customer complaint revealed that the ventilator's software calculates oxygen consumption using a smaller margin than required when treating small pediatric patients with high airway resistance and low lung compliance. This discrepancy means the device may not accurately reflect the necessary oxygen consumption parameters for these specific clinical scenarios.
The affected ventilators were distributed nationwide in the United States and in Switzerland. Healthcare facilities and users should contact Hamilton Medical Inc to verify their software version and part numbers. If the device is affected, it should be removed from service and replaced or updated according to the manufacturer's instructions.
The recalled product
- Product
- HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
- Manufacturer
- Hamilton Medical Inc
- Category
- Medical Device — Ventilator
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)
- Software Versions 1.1.2 and below
- Part numbers 161005
- 161006.
Distribution
Distributed nationwide across the United States.
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