HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Ha

FDA device recall Z-0170-2014 · posted 2013-11-06 · Terminated

Recall details

Recalling firm

Hamilton Medical, Inc.

Reason for recall

Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.

Action taken

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

Root cause

Device Design

Status

Terminated

Product code

CBK

Quantity affected

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.

Date initiated

2013-09-26

Date posted

2013-11-06

Date terminated

2018-03-29

Location

Reno, NV

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