Omega Systems These devices are intended to be used in recall: Software Issue
Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians…
Why was Omega Systems These devices are intended to be used in recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All software versions, all serial numbers.
- Product
- Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians…
- Recalling firm
- Draegar Medical Systems, Inc.
- Quantity
- 10699 in total
- Distribution
- US Nationwide distribution including Puerto Rico.
- Recall date
- March 13, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)