Another Class I Recall Issued for Hamilton Medical Ventilators

For the second time this year, a Class I recall has been issued for Hamilton Medical ventilators. Class I is the U.S. Food and Drug Administration’s (FDA’s) most serious recall status; it means that exposure to the recalled device presents a reasonable risk of serious injury or death. According to Fierce Medical Devices, the most recent recall was issued because the Hamilton-G5 ventilators may inadvertently suppress ventilation alarms when the operator activates a suctioning maneuver. This defect may occur regardless of whether the system is being used on a neonatal, pediatric or adult patient.

The recall affects 1,126 machines in the United States with software versions between V2.00 and 2.31. The Swiss-based company sent recall letters to customers in April, but the FDA only publicized the matter this week, Fierce Medical Devices reports.

The FDA also placed a Class I label on a recall of the Hamilton-G5 ventilators with software versions V2.40 and 2.41 in June. The recall was issued following complaints that the display may freeze which can cause the device to stop working. In 2013, another Class I recall was issued for Hamilton-T1 ventilators with software versions 1.12 and lower due to software problems that could cause inappropriate amounts of oxygen to be delivered.

from Parker Waichman http://www.yourlawyer.com/blog/another-class-i-recall-issued-for-hamilton-medical-ventilators/