FDA Enforcement
Class II
Ongoing
Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
Recall: Z-0975-2019
·
Reported March 13, 2019
Enforcement
- Recall Number
- Z-0975-2019
- Event ID
- 82014
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Draegar Medical Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 13, 2019
- Initiation Date
- February 8, 2019
- Classification Date
- March 5, 2019
- Address
- 6 Tech Dr, N/A, Andover, MA, 01810-2434, United States
Description
Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
Reason
The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.
Code Info
All software versions, all serial numbers.
Distribution
US Nationwide distribution including Puerto Rico.
Quantity
10699 in total