The Recall Desk

FDA (Devices) recall action 81182

GE Healthcare, LLC recalled 3 products on 2018-11-21

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2018-11-21
Critical
0
Units
12,621

Why these products were recalled

Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing 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 agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • SevereFDA (Devices)··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.

    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…
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2018-11-21

    GE Healthcare Recalls Aisys Anesthesia Systems for Missing Backup Ventilation Feature

    GE Healthcare is recalling Aisys anesthesia systems because a software upgrade prevents the device from automatically switching to backup ventilation if a patient stops breathing.

    Product
    Aisys 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 GERMAN…
    Category
    Distribution
    34 states
  • HighFDA (Devices)··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.

    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…
    Category
    Distribution
    34 states