The Recall Desk
SevereFDA (Devices)·Z-0413-2019·Announced 2018-11-21

GE Healthcare Recalls Aisys Anesthesia System Touchscreen Display Kits

GE Healthcare is recalling 4,207 Aisys anesthesia system touchscreen display kits because they fail to transition to backup ventilation if a patient stops breathing.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a critical failure in a life-support medical device (anesthesia system) that could result in serious injury or death if backup ventilation is not provided, aligning with the 'Severe' criteria for significant injury reports or high-risk device defects.

Plain-English summary

GE Healthcare, LLC is recalling 4,207 touchscreen display kits for the GE Datex-Ohmeda Aisys Anesthesia System. The affected units are distributed worldwide, including in the United States and numerous international markets. The kits are sold under various product names, such as TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, and are identified by specific model and serial numbers listed in the recall notice.

The recall is due to a software defect in the PSVPro Spontaneous Breathing Modes. Specifically, the devices do not provide the feature of transitioning to SIMV PCV backup ventilation mode if a patient stops spontaneous breathing while the PSVPro mode is in use prior to the clinician starting the Cycling Procedure. This failure could prevent the device from providing necessary ventilatory support in critical situations.

The Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients, including neonatal, pediatric, and adult patients. The device is intended for volume or pressure control ventilation. Users should check their device serial numbers against the list provided by the FDA and contact GE Healthcare for instructions on how to resolve the issue.

The recalled product

Product
Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPL
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Anesthesia System
Hazard
Affected units
4,207

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 (20)

  • Model Number
  • UDI Number
  • (Serial Number): 2097673-001-US (4651698-1)
  • 2097673-001-US (4651698-3)
  • 2097673-001-US (4651698-4)
  • 2097673-001-US (4651726-1)
  • 2097673-001-US (4652206-1)
  • 2097673-001-US (4652206-2)
  • 2097673-001-US (4649618-1)
  • 2097673-001-US (4649618-2)
  • 2097673-001-US (4649618-3)
  • 2097673-001-US (4649618-4)
  • 2097673-001-US (4649618-5)
  • 2097673-001-US (4653227-1)
  • 2097673-001-US (4653227-2)
  • 2097673-001-US (4653227-3)
  • 2097673-001-US (5474296-1)
  • 2097673-001-US (4652587-1)
  • 2097673-001-US (4652587-2)
  • 2097673-001-US (4652587-3)

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 3 recalled by GE Healthcare, 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 3 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · ventilation failure

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