Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog N...

FDA Device Recall #Z-0692-2016 — Class I — December 22, 2015

Recall Summary

Recall Number Z-0692-2016
Classification Class I — Serious risk
Date Initiated December 22, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Draeger Medical, Inc.
Location Telford, PA
Product Type Devices
Quantity 402 units (314 - Oxylog 3000; 88 - Oxylog 3000 Plus)

Product Description

Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.

Reason for Recall

Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.

Distribution Pattern

Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

Lot / Code Information

All Oxylog 3000 Ventilators and Oxylog 3000 Plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.

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.