GE Healthcare recalls 9100c NXT systems with August 2020 flow sensors that could cause tube punctures. Affected units were sold outside the US only.
Flow sensors could have damaged tubes in the form of small punctures or cuts.
GE Healthcare is recalling certain 9100c NXT systems that have flow sensors manufactured in August 2020. These sensors could cause small punctures or cuts in medical tubes during use, potentially leading to complications in medical procedures.
Flow sensors with an August 2020 manufacturing date could cause small punctures or cuts in medical tubes. This might lead to complications during medical procedures if the tubes are damaged.
Healthcare facilities using the 9100c NXT system with August 2020 flow sensors are most at risk. The product was only licensed for distribution outside the US, so US users are not affected.
Check for flow sensors with an etched manufacturing date of August 2020. The 9100c NXT system was only licensed for distribution outside the United States.
Look for an etched manufacturing date on the flow sensor that says August 2020.
No. The 9100c NXT system was only licensed for distribution outside the US.
Small punctures or cuts in medical tubes could occur, potentially leading to complications during medical procedures.
Check for flow sensors with an etched manufacturing date of August 2020. The device was only licensed for distribution outside the United States.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0314-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0314-2021 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.
