Hamilton Medical Recalls HAMILTON-C2 Ventilators Due to Loudspeaker Defects
Hamilton Medical is recalling 316 HAMILTON-C2 ventilators because the alarm system loudspeakers exceeded manufacturer-defined limits for improper functioning.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a critical safety feature (alarm system) is malfunctioning. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Hamilton Medical, Inc. is recalling 316 HAMILTON-C2 ventilators distributed in the United States. The recall is due to manufacturer-defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system being exceeded.
The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants, and neonates. It is used in intensive care wards, recovery rooms, and during the transfer of ventilated patients within hospitals. The devices were distributed nationwide, including in Puerto Rico and various states.
Affected devices have serial numbers from 1000-7100. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics…
- Manufacturer
- Hamilton Medical, Inc.
- Category
- Medical Device — Ventilator
- Hazard
- Affected units
- 316
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Hamilton-C2
- Serial numbers from 1000-7100.
Distribution
Related recalls
Same manufacturer · Hamilton Medical, Inc.
See all →- SevereIntensive Care Ventilators Recalled Due to Capacitor Degradation Risk
FDA (Devices) · 2023-09-27
- SevereHamilton-T1 Ventilator Recall: Degrading Capacitors May Interrupt Ventilation
FDA (Devices) · 2023-09-27
- SevereHamilton-T1 Ventilator Recalled Due to Degrading Capacitors That May Interrupt Ventilation
FDA (Devices) · 2023-09-27
- SeverePortable Intensive Care Ventilator Recalled for Degrading Capacitor Issue
FDA (Devices) · 2023-09-27
- SevereVentilator Control Board Spare Parts Recalled Due to Electrical Short-Circuit Risk
FDA (Devices) · 2023-09-27
Same hazard · alarm failure
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- HighTreatlife smoke and carbon monoxide detectors can fail to alarm
CPSC · 2026-06-25
- SevereAutomated Impella Controllers recalled over alarm, power and purge cassette faults
FDA (Devices) · 2026-06-03
- HighVital Sync remote monitoring may not receive bedside monitor alarms
FDA (Devices) · 2026-03-18
- HighSmoke alarms recalled because they may not sound in time
CPSC · 2026-02-12
Similar recalls
- SevereHamilton C2 Ventilator recalled for software anomaly causing loss of function
FDA (Devices) · 2023-08-02
- HighHamilton-C1 Ventilator Recall Due to Control Board Component Defect
FDA (Devices) · 2018-08-22
- HighHamilton-C2 Ventilator Units Recalled Due to Battery Fuel Gauge Inaccuracy
FDA (Devices) · 2018-04-18
- SevereHAMILTON C1 Ventilator Recalled for Software Defect Causing Unexpected Shutdown
FDA (Devices) · 2023-08-02
- HighHamilton-C3 Ventilator Recalled Due to Control Board Component Defect
FDA (Devices) · 2018-08-22
- CriticalHamilton Medical Recalls HAMILTON-G5 Ventilators Due to Alarm Suppression Defect
FDA (Devices) · 2015-11-11