FDA Device recall Z-2020-2024
Ventilator HAMILTON-C6, PN: 160021
- FDA Device
- Class I
- ongoing
- Published 2024-06-26
On 2024-06-26 the FDA classified a Class I recall of Ventilator HAMILTON-C6, PN: 160021 by Hamilton Medical Ag, citing ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichmen….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2020-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-05-15 |
| Published | 2024-06-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Hamilton Medical Ag |
| Distribution | US |
Product
Ventilator HAMILTON-C6, PN: 160021
Reason
Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.
Identifiers
| code_info | UDI: 07630002808590, Software Versions: SW v1.1.4, SW v1.1.5, SW v1.1.6 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2020-2024%22
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