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U.S. Department of Health and Human Services

Class 2 Device Recall Hamilton C2 Ventilator

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 Class 2 Recall
Hamilton C2 Ventilator
see related information
Date Posted November 06, 2013
Recall Status1 Open
Recall Number Z-0170-2014
Recall Event ID 66408
Premarket Notification
510(K) Number
K121225 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
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.
Code Information Hamilton-C2; Serial numbers from 1000-7100.
Recalling Firm/
Manufacturer
Hamilton Medical, Inc.
4990 Energy Way
Reno, Nevada 89502-4123
For Additional Information Contact Robert Hamilton
775-426-6331 Ext. 210
Manufacturer Reason
for Recall
Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.
FDA Determined
Cause 2
DESIGN: Device Design
Action Hamilton Medical sent an Medical Device Safety Alert and Corrective Action letter dated September 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The corrective action does not require any action by the operator. In the case of an alarm situation as described in the letter, users should follow the instruction for use (Section 8 - responding to alarms in the operator manual) and have the ventilator serviced by an authorized service technician. An addendum to the Operators Manual as a result of the field correction was provided to customers with the Safety Alert Letter. Manufacture will develop and provision a test protocol for the service tech which test the proper functioning of the loudspeaker during the annual service inspection. We appreciate your support in this matter and sincerely regret any inconveniences that this action may cause you. We consider this action as necessary to ensure that our customers receive only safe and effective products with high quality. Further questions please call (775) 426-6331 Ext. 210.
Quantity in Commerce 316 devices distributed in the US.
Distribution Nationwide distribution: USA including Puerto Rico and the states of IL, MT, IN, ND, AZ, MT, KY, NC, OH, MA, MO, VA, CA, NV, TX, WA, NY, GA, SC,MN, WY, PA, ND, UT, NE, CO and MI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = HAMILTON MEDICAL AG
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