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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a software defect that could lead to inaccurate clinical parameters for vulnerable pediatric patients. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
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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