FDA Device recall Z-1371-2018
Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hosp…
- FDA Device
- Class II
- ongoing
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hosp… by Hamilton Medical Ag, citing after two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1371-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-03-12 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hamilton Medical Ag |
| Distribution | AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MI, MN, MO, MT, NC, ND, NE, NV, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA |
Product
Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
Reason
After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
Identifiers
| code_info | Product No. 160001 All Serial Numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1371-2018%22
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