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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Event Detail

Event ID 66408
Product Type Devices
Status Ongoing
Recalling Firm Hamilton Medical, Inc.
City Reno
State NV
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-26
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Hamilton-C2; Serial numbers from 1000-7100. Class II Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded. 316 devices distributed in the US. Z-0170-2014
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