HAMILTON-T1 Ventilator with software versions 1.1.2 or recall: Software Issue
HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support…
Why was HAMILTON-T1 Ventilator with software versions 1.1.2 or recalled?
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 must be calculated using a larger margin than originally expected.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Versions 1.1.2 and below; Part numbers 161005, 161006.
- 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…
- Recalling firm
- Hamilton Medical Inc
- Quantity
- 97 total ventilators; 69 of part number 161005 and 28 of part number 161006
- Distribution
- US Nationwide Distribution including the country of Switzerland.
- Recall date
- February 6, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)