The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0412-2019·Announced 2018-11-21

GE Healthcare Recalls Aisys Anesthesia Systems Due to Ventilation Mode Defect

GE Healthcare is recalling Aisys anesthesia systems because they may fail to transition to backup ventilation if a patient stops breathing spontaneously.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 medical device with a functional defect that could prevent backup ventilation for a patient who stops breathing, representing a risk of harm where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 4,207 units of Aisys CS2 Anesthesia Systems and upgraded Aisys anesthesia devices. The recall involves devices sold under various product names, including AISYS and specific upgrade kits for different languages.

The recall is due to a defect in the PSVPro Spontaneous Breathing Modes. These modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure. The device is intended to provide general inhalation anesthesia and ventilatory support to neonatal, pediatric, and adult patients.

The affected units were distributed worldwide, including in the United States and numerous international countries. Healthcare facilities should contact GE Healthcare for instructions on how to address the defect.

The recalled product

Product
Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT…
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Anesthesia Machine
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): 1011-9050-000
  • 010084068210229221APWX0132811180608
  • (APWX01328)
  • 1011-9050-000
  • 010084068210229221APWX0048411180208
  • (APWX00484)
  • 010084068210229221APWW0214911171214
  • (APWW02149)
  • 10084068210229221APWW0215011171214
  • (APWW02150)
  • 010084068210229221APWX0026111180118
  • (APWX00261)
  • 010084068210229221APWX0026211180118
  • (APWX00262)
  • 010084068210229221APWX0140911180618
  • (APWX01409)
  • 010084068210229221APWX0141011180618
  • (APWX01410)

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 →

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