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.
What this means for you
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, infan
- 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
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