HAMILTON-T1 recallZ-2526-2023 · 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-2526-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 26, 2023
- Posted by the FDA
- Sep 20, 2023
- Recalling firm
- Hamilton Medical, Inc.
- Quantity
- 76 units
- Product code
- CBK
- FDA submissions
- K181216
- Distribution
- Distribution US nationwide, including Puerto Rico. OUS: Not provided
Product description
Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
Code information (models, lots, serial numbers)
UDI: 07630002801850 & 07630002813532 / Affected Serial Numbers: 15929 17600 17661 17677 17698 17699 17741 17850 17877 17913 17925 17955 17957 17969 17975 17976 17982 17985 17986 17991 17993 17995 18009 18166 18183 18189 18191 18199 18224 18244 18251 18255 18256 18260 18263 18272 18273 18276 18288 18289 18305 18308 18333 18340 18349 18360 18363 18377 18378 18383 18414 18415 18419 18441 18451 18458 18461 18502 18537 18544 18550 18778 18784 19237 19290 19291 19292 19293 19294 19298 19304 19305 19470 19483 19490 26117
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- HAMILTON-T1 161006Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls1 death471 reports
- HAMILTON-T1 1610060Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls3 deaths159 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-2527-2023 · Open, ClassifiedHamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
- Z-2528-2023 · Open, ClassifiedHamilton-MR1, REF: 161010, Intensive Care 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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