FDA Device recall Z-0316-2021
Flow Sensor Service Part, Catalog 2087640-001-S
- FDA Device
- Class II
- ongoing
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of Flow Sensor Service Part, Catalog 2087640-001-S by Ge Healthcare, citing flow sensors could have damaged tubes in the form of small punctures or cuts.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0316-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-09-17 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI |
Product
Flow Sensor Service Part, Catalog 2087640-001-S
Reason
Flow sensors could have damaged tubes in the form of small punctures or cuts.
Identifiers
| code_info | Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020). This flow sensor is compa…Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020). This flow sensor is compatible with the following device models: 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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0316-2021%22
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