GE Healthcare recalls Aisys CS2 anesthesia systems with PSVPro Spontaneous Breathing Modes that fail to transition to SIMV PCV backup ventilation if patient stops breathing. Affected units sold under AISYS, AISYS 10.X TO 11.X UPGRADE KIT variants. No remedy specified in recall.
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 certain Aisys CS2 anesthesia systems that have a problem with the PSVPro Spontaneous Breathing Mode feature. These devices do not automatically switch to SIMV PCV backup ventilation if a patient stops breathing while the PSVPro mode is active. This could lead to inadequate ventilation during critical patient events. The recall affects specific model versions sold under various product names.
The PSVPro Spontaneous Breathing Mode in these devices does not transition to SIMV PCV backup ventilation when a patient stops breathing. This means the system may not provide critical backup ventilation during an emergency event, potentially leading to inadequate patient support.
Healthcare providers using the Aisys CS2 anesthesia system for patient ventilation are most at risk. The recall applies to specific model versions sold in the U.S. and other regions.
Check if your device has a model number starting with 1011-9050-000 and a serial number (APWX, APWW, or APWX00000) listed in the provided serial numbers. The product was sold under names like AISYS, AISYS 10.X TO 11.X UPGRADE KIT variants.
Verify your device's model number starts with 1011-9050-000 and has a serial number in the list provided in the recall.
The PSVPro Spontaneous Breathing Mode does not transition to SIMV PCV backup ventilation if a patient stops breathing while the PSVPro mode is active.
Check if your device has a model number starting with 1011-9050-000 and a serial number listed in the provided serial numbers (e.g., APWX00000, APWW00000).
The recall does not specify a remedy; the official notice states the remedy is null.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0412-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0412-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
