HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients
Reported: November 11, 2015 Initiated: April 22, 2014 #Z-0151-2016
Product Description
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients
Reason for Recall
Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult).
Details
- Recalling Firm
- Hamilton Medical, Inc.
- Units Affected
- 1128
- Distribution
- Nationwide Distribution
- Location
- Reno, NV
Frequently Asked Questions
What product was recalled? ▼
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. Recalled by Hamilton Medical, Inc.. Units affected: 1128.
Why was this product recalled? ▼
Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2015. Severity: Critical. Recall number: Z-0151-2016.
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