HAMILTON-MR1 recallZ-2528-2023 · Hamilton Medical, Inc. · initiated Jul 26, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hamilton Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On July 26, 2023, Hamilton Medical issued Urgent Medical Device Correction via E-Mail. Hamilton Medical asked consignees to take the following actions 1. Check for affected devices in your facility. Get in contact with your local distribution partner and get the devices serviced with high priority. 2. Please sign the enclosed/attached sheet to confirm that, as an End- Customer, you have received and duly noted this Medical Device Correction.
Recall details
- Recall number
- Z-2528-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 26, 2023
- Posted by the FDA
- Sep 20, 2023
- Recalling firm
- Hamilton Medical, Inc.
- Quantity
- 12 units
- Product code
- CBK
- FDA submissions
- K153046
- Distribution
- Distribution US nationwide, including Puerto Rico. OUS: Not provided
Product description
Hamilton-MR1, REF: 161010, Intensive Care Ventilator
Code information (models, lots, serial numbers)
UDI: 07630002800761 & 07630002813556 / Affected Serial Numbers: 3422 3423 3424 3425 3426 3427 3428 3429 3469 3503 3510 3800
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- HAMILTON-MR1 161010Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls3 deaths132 reports
- HAMILTON-MR1 1610100Hamilton Medical AG · Ventilator, Continuous, Facility Use1 recall19 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 92873).
- Z-2525-2023 · Open, ClassifiedHamilton-C1, REF: 161001, Portable Intensive Care Ventilator
- Z-2526-2023 · Open, ClassifiedHamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
- Z-2527-2023 · Open, ClassifiedHamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
- Z-2530-2023 · Open, ClassifiedHamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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