Atlan A350XL. Model Number: 8621600. anesthesia workstation

FDA device recall Z-2208-2026 · posted 2026-06-04 · Open, Classified

Recall details

Recalling firm

Draeger, Inc.

Reason for recall

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Action taken

Draeger notified consignees of the recall update and expansion on about 05/07/2026 via emailed letter titled Urgent Medical Device Correction Update. Consignees were made aware that due to continuous monitoring, Draeger has determined that an additional number of Atlan devices are affected by the issue and they are replacing ventilator motors. Consignees were instructed that a Draeger Service Representative will contact consignees to arrange a date for the ventilator motor assembly replacement, and until the corrective action is implemented, the device may continue to be used with the customary care by only using the device under permanent supervision in line with the Atlan Instructions for Use. If the mechanical ventilation fails, use Man/Spont ventilation mode to ventilate the patient manually as needed. Consignees were also instructed to complete and return the provided Medical Device Correction Return Response Acknowledgment and Receipt Form and if products have been made available to third parties, please forward this Urgent Medical Device Correction notice to them.

Root cause

Process change control

Status

Open, Classified

Product code

BSZ

Quantity affected

394 units

Distribution

US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulga

Date initiated

2026-05-07

Date posted

2026-06-04

Location

Telford, PA

Related 510(k) clearances