The Recall Desk
HighFDA (Devices)·Z-0316-2021·Announced 2020-11-11

GE Healthcare Recalls Flow Sensor Service Parts with Damaged Tubes

GE Healthcare is recalling 388 Flow Sensor Service Parts because the tubes may have small punctures or cuts.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a physical defect (damaged tubes) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 388 units of the Flow Sensor Service Part, Catalog 2087640-001-S. The recall is due to a defect where the flow sensors could have damaged tubes in the form of small punctures or cuts.

The affected devices have an etched manufacturing date of 2020-08 (August 2020). These flow sensors are compatible with several GE Healthcare device models, including the Aespire 7100/11, Aespire 7900, Aespire View, Aestiva 7100, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2, Amingo (OUS), and 9100c NXT (OUS).

The product was distributed in 36 U.S. states and 26 foreign countries. Users should contact GE Healthcare for instructions on how to proceed with the recall.

The recalled product

Product
Flow Sensor Service Part, Catalog 2087640-001-S
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Anesthesia / Respiratory
Hazard
Affected units
388

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • Aespire 7900
  • Aespire View
  • Aestiva 7100
  • Aestiva 7900
  • Aestiva MRI
  • Aisys
  • Aisys CS2
  • Avance
  • Avance CS2
  • Amingo (OUS)
  • and 9100c NXT (OUS)

Distribution

Distributed in 36 states:

Part of a larger recall action

This product is one of 7 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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Same hazard · physical defect

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