UK regulator warns hospitals to check Dräger Atlan anaesthesia workstations after expanded safety action

The U.K. medicines regulator on Tuesday warned hospitals to check whether they use affected Dräger Atlan anaesthesia workstations after the manufacturer expanded a safety action over a defect that can cause mechanical ventilation to fail before or during use.

The Medicines and Healthcare products Regulatory Agency, which oversees medical devices in Britain, published Device Safety Information DSI/2026/005 on Aug. 4, titled “Dräger Atlan Anaesthesia workstations: risk of ventilator failure.” It said users should “identify whether your site uses Atlan Anaesthesia workstations and check if the devices are listed as affected in the FSN.”

The affected models named by the MHRA are the Atlan A100, A100 XL, A300, A300 XL, A350 and A350 XL, made by Drägerwerk AG & Co. KGaA of Lübeck, Germany. The agency said a manufacturing or assembly deviation may cause a fault in the ventilator motor electronics, known as the encoder. If that happens, the piston ventilator can fail before use, meaning mechanical ventilation cannot be started, or fail during use after ventilation has begun. In those cases, the machine displays “Ventilator error!!!!” and sounds an alarm. The MHRA said manual or spontaneous ventilation remains available, but warned that interruption of mechanical ventilation in an operating setting can lead to hypoxia and potentially death if it is not recognized and managed quickly.

The regulator told hospitals to determine whether any Atlan machines on site are covered by Dräger’s field safety notice and to follow interim precautions until repairs are completed. “Whilst waiting for Dräger to replace the motor assemblies, affected devices can continue to be used only with permanent supervision as per the instructions for use,” the MHRA said. Staff should be prepared to switch to manual ventilation if needed and be familiar with local escalation procedures. Dräger is replacing the ventilator motor assembly in affected devices, and the company’s service representatives are expected to contact customers to arrange the work.

The MHRA said the issue is serious but that no harm has been confirmed so far. “As of 29 July 2026, the manufacturer reports no confirmed patient injuries or deaths associated with this issue,” it said.

The British notice follows an April 2026 follow-up Field Safety Notice from Dräger that expanded the number of affected Atlan devices after continued monitoring identified additional units. That follow-up extends a previous safety action first issued in October 2024, meaning the problem is not newly identified but now covers a broader set of machines. In the United States, the Food and Drug Administration classified the related action as a Class 1 recall or correction, its highest risk category. The FDA said, “This device may cause serious injury or death if you continue to use it without correction,” and its database lists 3,515 units in commerce.