Draegar Medical Systems Recalls Omega Patient Monitor Software
Draegar Medical Systems is recalling Omega patient monitor software due to cybersecurity vulnerabilities that may cause device reboots or loss of functionality.
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 with cybersecurity vulnerabilities that may cause loss of functionality or communication, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Draegar Medical Systems, Inc. is recalling the Omega Systems patient monitor software. The recall involves 10,699 units distributed nationwide in the United States, including Puerto Rico. The devices are intended for use by healthcare professionals, including physicians, nurses, and technicians, in patient care environments.
The recall is being conducted due to cybersecurity vulnerabilities in the software. These vulnerabilities may cause the device to reboot, lose functionality, and/or lose communication. The recall covers all software versions and all serial numbers of the affected devices.
Healthcare facilities should contact Draegar Medical Systems for further instructions on how to address the cybersecurity vulnerabilities and ensure the continued safe operation of the devices.
The recalled product
- Product
- 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
- Manufacturer
- Draegar Medical Systems, Inc.
- Category
- Medical Device — Patient Monitor
- Affected units
- 10,699
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)
- All software versions
- all serial numbers.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Draegar Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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