FDA Device recall Z-2528-2023
Hamilton-MR1, REF: 161010, Intensive Care Ventilator
- FDA Device
- Class I
- ongoing
- Published 2023-09-27
On 2023-09-27 the FDA classified a Class I recall of Hamilton-MR1, REF: 161010, Intensive Care Ventilator by Hamilton Medical, citing degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to l….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2528-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-07-26 |
| Published | 2023-09-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hamilton Medical |
| Distribution | US |
Product
Hamilton-MR1, REF: 161010, Intensive Care Ventilator
Reason
Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.
Identifiers
| code_info | UDI: 07630002800761 & 07630002813556 / Affected Serial Numbers: 3422 3423 3424 3425 3426 3427 3428 3429 3469 3503 3510 3800 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2528-2023%22
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