UNITED STATES – As reported online by www.medtechdive.com and according to a safety notification published by www.fda.gov, Hamilton Medical AG has issued a recall of its Hamilton-G5 ventilators after learning of a software error that can cause the ventilators to stop working.
The United States Food and Drug Administration (FDA) has released a public health notification communicating the recall of Hamilton-G5 ventilators manufactured and sold by Hamilton Medical AG. According to the FDA’s notification, the Hamilton-G5 ventilators have been recalled after discovering the error message “panel connection lost” has been causing the ventilators to shut down, failing to assist patients with breathing.
The Hamilton-G5 ventilators are used in the hospital setting to treat patients in the emergency room, intensive care unit, for surgical procedures, and for any other use that provides breathing assistance to patients of all ages. If the ventilator stops working, patients no longer have the needed breathing assistance, which places them at risk of suffering harm. The FDA has designated the Hamilton-G5 recall as “Class I,” the most serious type of recall. Class I recalls are issued when a medical device has the potential to cause serious injuries or death.
Specific Hamilton G-5 Recall Information
Hamilton Medical AG voluntarily recalled certain Hamilton-G5 ventilators in February 2019. The FDA recently provided the following information about the specific ventilators subject to recall:
- Device Name: Hamilton Medical AG Hamilton-G5 Ventilator (PN 159001)
- Serial Numbers: All serial numbers below 16192 with software versions ≤ 2.60
- Manufacturing Dates: November 29, 2007 – October 31, 2018
- Distribution Dates: November 29, 2007 – October 31, 2018
- Devices Recalled in the U.S.: 4,338 Units
- Date Initiated by Firm: February 11, 2019
Hamilton Medical AG has instructed all customers to cease using the affected ventilators until the ventilators can be updated with software version 2.80, which will reduce the likelihood of receiving the error message “panel connection lost.”
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