Draeger Atlan Anesthesia Workstation Recalled for Ventilator Malfunction

Plain-English summary

Draeger, Inc. is recalling 223 Atlan A350XL anesthesia workstations (Model 8621600) due to a potential failure of the piston ventilator mechanism. The device may either indicate a ventilator failure before use or fail to provide mechanical ventilation during patient care.

Affected units were distributed across 23 US states (AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, PA, TX, UT, VA, WI) and exported to 38 countries including Argentina, Australia, Belgium, Brazil, China, France, Germany, India, Italy, Japan, Mexico, the Netherlands, South Korea, Spain, Switzerland, the United Kingdom, and Vietnam. The recall affects devices identified by serial numbers beginning with ASTA, ASTB, ASTC, ASTD, ASTH, ASTJ, ASUA, ASUB, ASUC, and ASUD.

Ventilator malfunction in an anesthesia workstation creates a serious risk during surgical and diagnostic procedures, potentially affecting the device's ability to provide critical mechanical ventilation or pressure-supported breathing. Healthcare providers should verify their device serial numbers against the recall list and contact Draeger, Inc. for corrective action instructions.

The recalled product

Product

Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ve

Manufacturer

Draeger, Inc.

Category

Medical Device — Anesthesia Equipment

Hazard

• ventilator-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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