GE Healthcare recalls Touchscreen Display Kit 11.X models for missing PSVPro ventilation mode transition feature, which could affect anesthesia safety during patient breathing stops.
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.
GE Healthcare is recalling Touchscreen Display Kit 11.X models because they don't properly switch to backup ventilation modes if a patient stops breathing. This could lead to unsafe anesthesia conditions during surgery.
The recalled devices fail to transition to SIMV PCV backup ventilation when a patient stops spontaneous breathing during PSVPro mode. This could cause inadequate breathing support if the patient's breathing stops, potentially leading to unsafe anesthesia conditions.
Healthcare providers using GE Datex-Ohmeda Aisys Anesthesia Systems with the recalled Touchscreen Display Kits. Patients receiving anesthesia in hospitals or clinics using these devices are at risk.
Check for Touchscreen Display Kit 11.X models with 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, TOUCHSCREEN DISPLAY KIT 11.X ESTONIAN, TOUCHSCREEN DISPLAY KIT 11.X ITALIAN, TOUCHSCREEN DISPLAY KIT 11.X NORWEGIAN. Model numbers include 2097673-001 with various serial numbers.
Identify your device model by checking the label on the device or the packaging for the model number and serial number.
Reach out to GE Healthcare directly to confirm if your device is affected and get instructions for next steps.
Yes, if you have GE Datex-Ohmeda Aisys Anesthesia Systems with the recalled Touchscreen Display Kit 11.X models, this recall applies.
Check the model number and serial number on your device. Affected models include 2097673-001 with specific serial numbers listed in the recall notice.
Contact GE Healthcare directly to confirm if your device is affected and get instructions for next steps.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0413-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0413-2019 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
