Recall Z-0151-2016— Hamilton Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by Hamilton Medical, Inc., initiated 2014-04-22, terminated 2017-08-24. It names one FDA 510(k) clearance: K131774. Product: 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: 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)..
- Recalling firm
- Hamilton Medical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-04-22
- Terminated
- 2017-08-24
- Firm location
- Reno, NV, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.