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Terminated

Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support.

FDA Recall Z-1443-2013 · Posted 2013-06-03

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeBSZ
Date Initiated2013-05-14
Date Terminated2014-03-12
Product Quantity800

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.

Firm Action

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.

Root Cause

Component change control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123125GE DATEX-OHMEDA AVANCE CS2Datex-Ohmeda, Inc. · 2013-02-06K122445AESPIRE 7900, AESPIRE VIEWDatex-Ohmeda · 2012-10-12K112722GE DATEX-OHMEDA AVANCEDatex-Ohmeda, Inc. · 2011-12-16K110213GE DATEX-OHMEDA AISYSDatex-Ohmeda, Inc. · 2011-07-20K090892GE DATEX-OHMEDA S/5 ADU CARESTATIONGE Healthcare Finland Oy · 2009-04-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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