GE Healthcare Aestiva 7900 Ventilator Recall for Stuck Valve Risk
GE Medical Systems is recalling two Aestiva 7900 ventilators because a stuck valve could cause excessive pressure and barotrauma.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (barotrauma) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Medical Systems, LLC is recalling two units of the GE Healthcare Aestiva 7900 ventilator (model 1006-9305-000). This device is a microprocessor-based, electronically controlled, pneumatically driven ventilator used in Datex-Ohmeda Aestiva/5 anesthesia systems to provide patient ventilation during surgical procedures.
The recall is due to a defect where the Drive Gas Check Valve could become stuck in a fixed open position. This malfunction could cause pressure to build in the mechanical ventilation cycle. If left unresolved, the issue could result in excessive or prolonged pressure in the patient breathing circuit during ventilation, potentially leading to barotrauma.
The affected units were distributed worldwide, including nationwide in the United States (excluding New Hampshire, Vermont, and Wyoming) and in numerous international locations. The source text does not specify instructions for consumers or healthcare providers regarding the immediate handling of these devices.
The recalled product
- Product
- GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during su
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — Ventilator
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- AMRU01022 AMRU01023
Distribution
Part of a larger recall action
This product is one of 6 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · GE Medical Systems, LLC
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- HighGE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
FDA (Devices) · 2026-07-22
- HighGE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall
FDA (Devices) · 2026-07-22
- HighGiraffe OmniBed incubator canopy fasteners can fall into patient compartment
FDA (Devices) · 2026-06-24
- HighGiraffe OmniBed replaceable units share the canopy fastener disengagement defect
FDA (Devices) · 2026-06-24
Same hazard · barotrauma
See all →- SevereVolara ventilator adapter recalled as Class I over desaturation and barotrauma
FDA (Devices) · 2026-04-08
- HighPhilips Trilogy Evo respiratory devices recalled for missing contraindication statement
FDA (Devices) · 2024-01-10
- SevereIn-Line Ventilator Adaptor Recall: Risk of Reduced Oxygenation or Barotrauma
FDA (Devices) · 2022-06-08
- HighBaxter ventilator adaptor recalled for potential oxygenation failure and barotrauma risk
FDA (Devices) · 2022-06-08
- HighGE Healthcare Anesthesia Systems Recalled for Potential Barotrauma Risk
FDA (Devices) · 2016-01-27