Canister: CO2 canister with GE part numbers 1407-3200-000… recallZ-1443-2013 · GE Healthcare, LLC · initiated May 14, 2013
Class II Terminated All recalls posted in June 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component change control
What the company is doing
GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter April 30, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Fax back form was included with the letter requesting the consignees to complete and return.
Recall details
- Recall number
- Z-1443-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 14, 2013
- Posted by the FDA
- Jun 3, 2013
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 800
- Product code
- BSZ
- FDA submissions
- K090892, K110213, K112722, K122445, K123125
- Distribution
- 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.
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.
Code information (models, lots, serial numbers)
Canisters with date code of 02-2013 (Feb 2013)
Other devices under the same FDA submission
2 devices cleared under K090892, K110213, K112722, K122445, K123125 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Avance CS2Datex-Ohmeda Inc · Gas-machine, anesthesia6 recalls1,540 reports
- Aespire 7900Datex-Ohmeda Inc · Gas-machine, anesthesia3 recalls48 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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