The Recall Desk
HighFDA (Devices)·Z-0315-2021·Announced 2020-11-11

GE Healthcare Recalls Flow Sensor Service Parts Due to Damaged Tubes

GE Healthcare is recalling 4,794 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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (damaged medical device components) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling 4,794 units of the Flow Sensor Service Part, Catalog 2089610-001-S. The recall was initiated because the flow sensors could have damaged tubes in the form of small punctures or cuts.

The affected devices are flow sensors with an etched manufacturing date of August 2020 (2020-08). These sensors are compatible with specific 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 35 U.S. states and 27 foreign countries. Users of these devices should check their flow sensors for the specified manufacturing date and contact GE Healthcare for further instructions.

The recalled product

Product
Flow Sensor Service Part, Catalog 2089610-001-S
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Anesthesia / Respiratory
Hazard
Affected units
4,794

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 →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · damaged tube

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