Recall Z-0975-2019— Draegar Medical Systems, Inc.

Name: FDA recall Z-0975-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-08

Class II · Ongoing

Class II FDA medical device recall by Draegar Medical Systems, Inc., initiated 2019-02-08. It names one FDA 510(k) clearance: K141756. 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..

Recalling firm: Draegar Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-02-08
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K141756 — INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATIONDraeger Medical Systems, Inc.·cleared 2014-12-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.