GE Healthcare Recalls Flow Sensor Service Parts Due to Damaged Tubes
GE Healthcare is recalling 2 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 source text does not report any illnesses or injuries, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 2 units of the Flow Sensor Service Part, Catalog 2096513-001-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 are flow sensors with an etched manufacturing date of 2020-08 (August 2020). 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, and 9100c NXT.
The product was distributed in 36 U.S. states and 26 foreign countries. Users of these devices should contact GE Healthcare for further instructions regarding the recall.
The recalled product
- Product
- Flow Sensor Service Part, Catalog 2096513-001-S
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 2
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
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.
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