Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow ane...
FDA Device Recall #Z-2253-2018 — Class II — May 24, 2018
Recall Summary
| Recall Number | Z-2253-2018 |
| 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 | 72 |
Product Description
Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration and identification. It is an inhalation anesthesia machine for use in operating, induction, and recovery rooms. It can be used with rebreathing systems, semiclosed to virtually closed systems with low flow and minimal flow techniques, and non-rebreathing systems (with the Auxiliary Common Gas Outlet). It may be used with O2, N2O, and Air supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine. The Apollo is equipped with a compact breathing system, providing fresh-gas decoupling, PEEP, and pressure limitation. It has an electrically driven and electronically controlled ventilator.
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-0152 ASKN-0138 ASKM-0193 ASKN-0139 ASKM-0202 ASKN-0143 ASKM-0203 ASKN-0144 ASKM-0211 ASKN-0148 ASKM-0212 ASKN-0150 ASKM-0213 ASKN-0151 ASKM-0214 ASKN-0152 ASKM-0221 ASKN-0163 ASKM-0222 ASKN-0164 ASKM-0227 ASKN-0165 ASKM-0228 ASLA-0001 ASKM-0246 ASLA-0002 ASKM-0269 ASLA-0003 ASKM-0272 ASLA-0092 ASKM-0328 ASLA-0121 ASKM-0332 ASLA-0124 ASKM-0333 ASLA-0131 ASKM-0337 ASLA-0132 ASKM-0339 ASLA-0145 ASKM-0340 ASLA-0146 ASKM-0360 ASLA-0152 ASKM-0362 ASLA-0153 ASKM-0366 ASLA-0154 ASKM-0370 ASLA-0163 ASKM-0371 ASLA-0164 ASKM-0408 ASLA-0165 ASKM-0409 ASLA-0166 ASKM-0415 ASLA-0173 ASKN-0012 ASLA-0174 ASKN-0035 ASLA-0175 ASKN-0039 ASLA-0179 ASKN-0040 ASLA-0180 ASKN-0113 ASLA-0181 ASKN-0114 ASLA-0182 ASKN-0116 ASLA-0183
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.