GE Healthcare recalls Aestiva/5 MRI Anesthesia Systems with flow sensors manufactured in August 2020 due to potential tube punctures. Affected units may require replacement to prevent injury during medical procedures.
Flow sensors could have damaged tubes in the form of small punctures or cuts.
GE Healthcare is recalling Aestiva/5 MRI Anesthesia Systems that were manufactured with flow sensors dated August 2020. These systems could cause small punctures or cuts in medical tubes during use, which might lead to complications during anesthesia procedures.
Flow sensors in the Aestiva/5 MRI Anesthesia System could cause small punctures or cuts in medical tubes. This might lead to complications during anesthesia procedures if the tubes become damaged.
Healthcare providers using the Aestiva/5 MRI Anesthesia System with flow sensors manufactured in August 2020 are most at risk. Patients receiving anesthesia through this system could be affected if the tubes develop punctures.
Check for flow sensors with an etched manufacturing date of August 2020. The system was sold as part of the Aestiva/5 MRI Anesthesia System, which includes features for use in MRI environments.
Look for an etched manufacturing date on the flow sensor; if it shows August 2020, the unit is affected.
The flow sensors in these units could cause small punctures or cuts in medical tubes during use, which might lead to complications during anesthesia procedures.
Check for flow sensors with an etched manufacturing date of August 2020. The system was sold as part of the Aestiva/5 MRI Anesthesia System.
The recall record does not specify a remedy or action for affected units.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0311-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0311-2021 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.
