Class I — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv |
| Product | GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation. |
| Quantity | 10,263 (3,194 US, 7,069 OUS) |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and Puerto Rico except DE, ME, NM, RI, and VT, and the countries of UNITED ARAB EMIRATES, JAPAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACEDONIA , MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUG… |
| Initiated | 2013-09-16 |
| Classified | 2013-10-15 |
| Terminated | 2015-10-01 |
| Recall number | Z-0009-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — GE Healthcare, LLC (Z-0009-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66381/
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