Recall Z-1512-2024— Draeger Medical, Inc.

Name: FDA recall Z-1512-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-20

Class I · Ongoing

Class I FDA medical device recall by Draeger Medical, Inc., initiated 2024-03-20. It names one FDA 510(k) clearance: K133886. Product: Dr¿ger Perseus A500 Anesthesia Workstation. Reason: Unexpected shutdown while operating on battery power..

Recalling firm: Draeger Medical, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2024-03-20
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K133886 — PERSEUS A500Draeger Medical GmbH·cleared 2014-06-20

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

Dr¿ger Perseus A500 Anesthesia Workstation

Reason for recall

Unexpected shutdown while operating on battery power.

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