FDA Device recall Z-0314-2021
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only
- FDA Device
- Class II
- ongoing
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of 9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only 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-0314-2021 |
| 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
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
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) |
|---|
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-0314-2021%22
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