Urgent Alert: Hamilton Medical Inc. Recalls Ventilators Due to Software Issues Poses Severe Risk to Patient Safety
Hamilton Medical Inc. has announced an urgent recall of its HAMILTON-C1, C2, C3, and T1 ventilators due to a software glitch that could potentially stop the machines without notice. This recall is classified as a Class I by the FDA—the most serious level, indicating that the use of these devices may lead to severe injuries or death.
Recalled Products
The recall involves four models of Hamilton ventilators:
- HAMILTON-C1 with SW version less than 2.2.10 and neonatal option installed
- HAMILTON-C2 with SW version less than 2.2.5 and neonatal option installed
- HAMILTON-C3 with SW version less than 2.0.9 and neonatal option installed
- HAMILTON-T1 with SW version less than 2.2.10 and neonatal option installed
Product Codes:
- HAMILTON C1 Ventilator REF: 161001/1610010
- HAMILTON C2 Ventilator REF: 160001
- HAMILTON C3 Ventilator REF: 160005
- HAMILTON T1 Ventilator REF: 161006/1610060/161009/1610090
Distribution Dates: December 10, 2010, to May 1, 2023
Devices Recalled in the U.S.: 21,429
Device Use
Hamilton ventilators are crucial devices that assist individuals who require partial or full breathing support. Health care providers use these ventilators in various settings, including intra-hospital and inter-hospital patient transport. These machines can be configured to support adults, children, and, optionally, infants and newborns.
The Core Issue
The recall was initiated after Hamilton Medical Inc. received 80 reported complaints (although no injuries or deaths have been reported) indicating that the devices could switch to ‘Ambient State’ if they operate for more than 91 days without a restart. Once the device switches to this state, it alarms and displays ‘Ambient State’ on the screen. This necessitates immediate intervention from healthcare providers to manually resuscitate the patient and switch to an alternative ventilation system, failing, which could result in severe consequences or death.
What Should Be Done?
Hamilton Medical Inc. has reached out to all affected customers with an Important Medical Device Advisory that requests them to:
- Immediately provide alternative ventilation to patients.
- Turn off the power of the faulty ventilator to exit the ‘Ambient State.’
- Service the device once patient safety is assured. After servicing, the device can be returned to operational status.
Customers with any questions or who require technical support are advised to contact Hamilton Medical AG Technical Support. Additionally, a full list of affected devices can be found in the Medical Device Recalls database.
Reporting Adverse Effects
Healthcare providers and consumers are encouraged to report any adverse reactions or quality issues related to these devices to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
It is crucial for everyone involved in patient care to recognize the severity of this issue and to act immediately to prevent any adverse effects. Immediate action is required to ensure the safety and well-being of patients.
If you or a loved one have been harmed by this recalled ventilator, you may be able to recover monetary compensation.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products. For your free consultation, contact our national product liability law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
.svg){kind=small}
.avif)
.avif)
