Draeger Atlan Recall is Class 1

FDA says the Draeger 10/15 recall (correction) for its Atlan A350 and A350XL anesthesia workstations is Class 1. An agency notice says the company sent customers an urgent medical device correction indicating that a company representative would make contact to arrange for a ventilator motor assembly replacement.

The notice says the correction was made due to a manufacturing error that may cause the piston ventilator to fail before use or mechanical ventilation to fail during use. Using an affected product may cause serious adverse health consequences, FDA says. The notice says there have been no reported deaths or injuries.

The anesthesia workstations are intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing, FDA says. The workstations are used for inhaled anesthesia during surgical or diagnostic procedures.