RecallRadar

FDA Device recall Z-0170-2014

HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland

On 2013-11-13 the FDA classified a Class II recall of HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland by Hamilton Medical, citing manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0170-2014
ClassificationClass II
Statusterminated
Initiated2013-09-26
Published2013-11-13
Last updated2026-09-13 11:53 UTC
CompanyHamilton Medical
DistributionUS

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.

Identifiers

code_infoHamilton-C2; Serial numbers from 1000-7100.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0170-2014%22

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