Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for us...
FDA Device Recall #Z-2254-2018 — Class II — May 24, 2018
Recall Summary
| Recall Number | Z-2254-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 24, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Draeger Medical, Inc. |
| Location | Telford, PA |
| Product Type | Devices |
| Quantity | 33 |
Product Description
Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is equipped with airway monitoring, gas measurement and device monitoring, O2 insufflation, and an anesthetic gas receiving system. Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents. Ventilation is accomplished on the patient through a laryngeal mask airway, a full-face mask, or an endotracheal tube. The integrated breathing system can be used with partial rebreathing (low-flow or minimum-flow). A non-rebreathing system such as the Kuhn or Medec Water System may be used at the external fresh-gas outlet (optional). Perseus is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.
Reason for Recall
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
Distribution Pattern
US Nationwide Distribution - Healthcare facilities in AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI, and WV.
Lot / Code Information
ASKM-0197 ASKN-0006 ASKN-0007 ASKN-0008 ASKN-0009 ASKN-0013 ASKN-0014 ASKN-0015 ASKN-0021 ASKN-0026 ASKN-0027 ASKN-0028 ASKN-0029 ASKN-0030 ASKN-0031 ASKN-0034 ASKN-0035 ASKN-0036 ASKN-0037 ASKN-0038 ASKN-0039 ASKN-0040 ASKN-0042 ASKN-0045 ASKN-0046 ASKN-0048 ASKN-0049 ASKN-0050 ASKN-0053 ASKN-0054 ASKN-0055 ASLA-0009 ASLA-0010
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.