FDA Device recall Z-0975-2019
Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Phy…
- FDA Device
- Class II
- ongoing
- Published 2019-03-13
On 2019-03-13 the FDA classified a Class II recall of Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Phy… by Draegar Medical Systems, citing 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 c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0975-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-02-08 |
| Published | 2019-03-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Draegar Medical Systems |
| Distribution | US |
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 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.
Identifiers
| code_info | All software versions, all serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0975-2019%22
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