Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intend...
FDA Device Recall #Z-1443-2013 — Class II — May 14, 2013
Recall Summary
| Recall Number | Z-1443-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 14, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 800 |
Product Description
Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support.
Reason for Recall
GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems. Reusable CO2 absorbent canisters accessories may not seal properly.
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, CT, ID, MK, MI, NJ, NY, OH, TN, TX, and VA, and the countries of INDIA, AUSTRALIA, BAHRAIN, BANGLADESH, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDONESIA, IRAQ,ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA,LEBANON, MALAYSIA, MEXICO, NETHERLAND,NEW ZEALAND, OMAN, PARAGUAY, PERU., PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, THAILAND, TURKEY, UNITED ARAB EMIRATES , UNITED KINGDOM, and VIET NAM.
Lot / Code Information
Canisters with date code of 02-2013 (Feb 2013)
Other Recalls from GE Healthcare, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1566-2022 | Class II | (1) GE Centricity Universal Viewer 6.0, Model 2... | Jul 15, 2022 |
| Z-1430-2022 | Class II | SIGNA Premier magnetic resonance scanner, model... | Jun 24, 2022 |
| Z-1466-2022 | Class II | Centricity PACS Software Version 7.0 SP0.0.4.7 | Jun 14, 2022 |
| Z-1333-2022 | Class II | GE Centricity Universal Viewer Zero Footprint. ... | Jun 8, 2022 |
| Z-1511-2022 | Class II | Service manuals for the CT, PET, or NM table as... | Jun 2, 2022 |
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.