Recall Z-0170-2014— Hamilton Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Hamilton Medical, Inc., initiated 2013-09-26, terminated 2018-03-29. It names one FDA 510(k) clearance: K121225. Product: HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.. Reason: Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded..
- Recalling firm
- Hamilton Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-26
- Terminated
- 2018-03-29
- 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-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.
Reason for recall
Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.
Data sourced from openFDA. This site is unofficial and independent of the FDA.