GE Healthcare recalls flow sensors from August 2020 with potential small punctures that could damage tubes. Affected models include Aespire 7100/11 and others. Return or replace as directed.
Flow sensors could have damaged tubes in the form of small punctures or cuts.
GE Healthcare is recalling flow sensors made in August 2020 that could cause small punctures or cuts in medical tubes. This poses a risk of tube damage during use, which could lead to complications in medical procedures.
The flow sensors may develop small punctures or cuts in the tubes they monitor. This can damage medical tubes during use, potentially causing leaks or blockages in critical medical procedures.
Healthcare providers using GE's Aespire, Aestiva, and Avance series devices with flow sensors from August 2020. Patients using these devices are at low risk if the sensors are functioning properly.
Check for flow sensors with an etched manufacturing date of August 2020. Affected devices include Aespire 7100/11, Aespire 7900, Aestiva 7100, and other GE medical devices listed in the recall notice.
Look for an etched manufacturing date on the flow sensor; if it shows August 2020, it is affected.
Reach out to GE Healthcare for instructions on returning or replacing the affected flow sensor.
No, the recall does not require immediate discontinuation. Affected devices can continue to be used with the flow sensor if it is not damaged.
Affected models include Aespire 7100/11, Aespire 7900, Aestiva 7100, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2, Amingo (OUS), and 9100c NXT (OUS).
Check for an etched manufacturing date of August 2020 on the flow sensor. This is the only identifier provided in the recall notice.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0317-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0317-2021 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.
