GE Healthcare recalls Aisys anesthesia systems with PSVPro Spontaneous Breathing Modes that fail to transition to SIMV PCV backup ventilation if patient stops breathing. Affected units include specific model numbers and serials.
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 anesthesia systems that have a defect in their PSVPro Spontaneous Breathing Mode. This defect means the system won't switch to SIMV PCV backup ventilation if a patient stops breathing while the PSVPro mode is active. This could lead to inadequate breathing support during critical medical procedures.
The PSVPro Spontaneous Breathing Mode in affected devices does not automatically switch to SIMV PCV backup ventilation when a patient stops breathing. This could result in inadequate breathing support if the patient's breathing stops while the PSVPro mode is active, potentially leading to complications during anesthesia procedures.
Healthcare professionals using GE Healthcare's Aisys anesthesia systems with specific model numbers and serial numbers listed in the recall. Patients receiving anesthesia through these systems are at risk if the defect causes breathing issues during surgery.
Check if your Aisys anesthesia system has model numbers like 1011-9000-000 or serial numbers listed in the recall, such as 5470345-30, 5470345-31, or 5470345-32. The recall includes specific product names and regional versions.
Review your Aisys anesthesia system's model number and serial number to see if they match the listed affected units in the recall.
Check if your model number or serial number matches the list provided in the recall. Affected units include specific model numbers like 1011-9000-000 and serial numbers such as 5470345-30, 5470345-31, or 5470345-32.
The recall does not specify a remedy, so contact GE Healthcare directly for guidance on next steps.
The recall states that the defect may prevent the system from switching to backup ventilation if a patient stops breathing, but it does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0411-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0411-2019 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.
