Food, drugs, devices › Hamilton Medical AG
Device recall: Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and n
FDA enforcement event 78599 is a device recall by Hamilton Medical AG of Bonaduz, initiated 12 Mar 2018 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Hamilton Medical AG has 12 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Hamilton Medical AG, Bonaduz, Switzerland.
Reason for recall
"After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available."
Distribution
"Worldwide Distribution -- USA, including the states of AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MI, MN, MO, MT, NC, ND, NE, NV, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, and WA; and, the countries of…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1371-2018 | Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital. | 739 units total | Class II | Ongoing | 18 Apr 2018 |
| Z-1372-2018 | Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital. | 739 units total | Class II | Ongoing | 18 Apr 2018 |
Context
Other enforcement events for Hamilton Medical AG
All 12 events for Hamilton Medical AG
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution -- USA, including the states of AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MI, MN, MO, MT, NC, ND, NE, NV, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, and WA; and, the countries of…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.