Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, childr...

FDA Device Recall #Z-0360-2016 — Class I — November 12, 2015

Recall Summary

Recall Number Z-0360-2016
Classification Class I — Serious risk
Date Initiated November 12, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Draeger Medical, Inc.
Location Telford, PA
Product Type Devices
Quantity 34

Product Description

Perseus A500 Anesthesia Workstation, MK06000. 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.

Reason for Recall

There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the following to occur: 1. The workstation has a fresh gas delivery failure and a ventilator failure with respective alarms. 2. The workstation shuts down completely with an audible alarm.

Distribution Pattern

US Distribution -- To the states of WI, PA, OH, ME, IL, and NY.

Lot / Code Information

ASHB-0140 ASHF-0039 ASHF-0055 ASHF-0056 ASHF-0057 ASHH-0008 ASHH-0009 ASHH-0010 ASHH-0011 ASHH-0012 ASHH-0013 ASHH-0014 ASHJ-0095 ASHJ-0096 ASHJ-0097 ASHJ-0098 ASHJ-0099 ASHK-0001 ASHK-0002 ASHK-0003 ASHK-0008 ASHK-0009 ASHK-0010 ASHK-0056 ASHK-0057 ASHK-0079 ASHK-0080 ASHK-0081 ASHK-0082 ASHK-oo83 ASHK-0084 ASHK-0085 ASHK-0086, and ASHK-0087.

Other Recalls from Draeger Medical, Inc.

Recall # Classification Product Date
Z-0668-2025 Class I Brand Name: Atlan Product Name: Atlan A300XL ... Oct 15, 2024
Z-0304-2025 Class I Brand Name: Atlan Product Name: Atlan A350 Mo... Oct 15, 2024
Z-0305-2025 Class I Brand Name: Atlan Product Name: Atlan A350XL ... Oct 15, 2024
Z-0667-2025 Class I Brand Name: Atlan Product Name: Atlan A300 ... Oct 15, 2024
Z-1512-2024 Class I Dr¿ger Perseus A500 Anesthesia Workstation Mar 20, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.