Class I — Hamilton Medical AG
| Recalling firm | Hamilton Medical AG |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When the ventilator enters the ambient state, alternative ventilation must be provided immediately. |
| Product | HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. |
| Quantity | 4338 units |
| Distribution | Worldwide Distribution- US (Nationwide Distribution): MI, WI, OR, MO, TX, NV, PA, SC, HI, MN, ND, NC, AZ, FL, CA, MA, GA, NY, VA, WA, IN, CO, LA, IL, OH, TN, SD, OK, MI, AR, C, AK, WV, NJ, IA, NE, KS, MT, NH, AL, MD, KY, CT, and RI. And (International Distribution): AT, BE, BG, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IT, MT, NL. NO, PL.PT, RO, SE, SI, SK, TR, HR. AGO, ARE, ARM, AUS, AZE, BGD… |
| Initiated | 2019-03-25 |
| Classified | 2019-07-11 |
| Terminated | 2024-06-03 |
| Recall number | Z-1874-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Hamilton Medical AG (Z-1874-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82328/
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