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Terminated

Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients within the hospital.

FDA Recall Z-2795-2018 · Posted None

Recalling FirmHamilton Medical AG
Recall StatusTerminated
Product CodeCBK
Date Initiated2018-03-09
Date Terminated2019-03-18
Product Quantity16 devices

Reason for Recall

An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side.

Firm Action

Hamilton Medical notified customers on about 03/09/2018 via letter. Instructions included that a Hamilton Medical Field Service Representative will be in contact with each customer to schedule the correction. Questions or concerns can be directed to Hamilton Technical Support at 1-800-426-6331, option #2.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US distribution to CA, CO, IL, LA, MN, NY, OK, VA, WI. Worldwide distribution to China, Germany, India, Indonesia, Israel, Kazakhstan, Korea, Pakistan, Taiwan, Poland, Armenia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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