Hamilton Medical Inc. Initiates Recall of HAMILTON-C1, C2, C3, T1 Ventilators Due to Software Glitches Leading to Unanticipated Shutdowns Creating Risks of Suffocation and Potential Brain Injuries.
The FDA has classified this recall as Class I, the most severe level of recall, due to the potential for serious harm or fatality associated with the use of these devices.
Recalled Product Details
Product Names and Versions:
- HAMILTON-C1 with Software version <2.2.10 and neonatal option included
- HAMILTON-C2 with Software version <2.2.5 and neonatal option included
- HAMILTON-C3 with Software version <2.0.9 and neonatal option included
- HAMILTON-T1 with Software version <2.2.10 and neonatal option included
Product Codes and Model Numbers:
The Referenced Codes include 161001/1610010, 160001, 160005, 161006/1610060/161009/1610090, covering models C1, T1 V2.2.x and prior, C2, and C3.
Distribution Timeline: December 10, 2010, to May 1, 2023
Device Utilization
Hamilton ventilators serve individuals necessitating complete or supplementary respiratory aid via a mechanical ventilator, deployed by medical personnel during intra or inter-hospital patient transfers. They are adaptable, catering to adults, children, and, optionally, infants and newborns.
Reason Behind the Recall
Hamilton Medical Inc. has initiated the recall of specific Hamilton ventilators, in response to reported software anomalies that can potentially lead to abrupt termination of the ventilator’s operation. If the ventilator is operational for over 91 days consecutively without a restart in the neonatal patient group, it will transition to an ‘Ambient State’.
During this state, the following alert and display indicators become evident. The indication of ‘Ambient state,’ revealing a technical malfunction on the device screen.
This scenario necessitates immediate intervention by a healthcare professional to supply air manually and possibly deploy an alternate device. The situation could escalate to severe ramifications or fatal outcomes if the patients, unable to breathe autonomously, do not receive immediate assistance.
The recall stems from 80 recorded complaints; however, no instances of injuries or fatalities have been reported in connection with this recall.
Affected Parties
- Individuals receiving respiratory support from the implicated Hamilton ventilators.
- Healthcare providers administering respiratory support with the specified Hamilton ventilators.
Recommended Actions
On June 15, 2023, Hamilton Medical Inc. dispatched an Important Medical Device Advisory to all concerned customers, instructing them to:
- Implement alternative ventilation strategies immediately.
- Deactivate the ventilator to exit ‘Ambient State.’
- Ensure patient safety before servicing the ventilator. (Post-service, the device is deemed fit for reuse.)
For inquiries regarding this recall, customers are advised to get in touch with Hamilton Medical AG Technical Support via email at techsupport@hamilton-medical.com or via the customer service number posted on the company’s website.
A comprehensive compilation of the impacted devices can be accessed in the Medical Device Recalls database.
Adverse reactions or quality complications experienced in association with the use of these devices should be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program through online forms, standard mail, or fax.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products. If you or a loved one have experienced complications, distress, or any adverse effects due to the use of the recalled Hamilton ventilators, it is pivotal to understand your legal rights and options. Parker Waichman LLP, a nationally recognized product injury law firm, is dedicated to representing victims of defective medical devices. We encourage you to reach out for a free, no-obligation consultation to discuss potential compensation for pain, suffering, and other damages related to this recall.
Contact us today at 1-800-YOUR-LAWYER (1-800-968-7529) to evaluate your case and determine the most appropriate course of action to ensure your rights are protected. Don’t delay; act now to secure the legal representation you deserve!
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