Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0413-2019 — 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 DISPLAY KIT 11.X DANISH,

U.S. FDA — Device Enforcement · United States · 2018-09-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0413-2019
Date of alert
2018-09-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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