Drger Perseus A500 Anesthesia Workstation

FDA device recall Z-1512-2024 · posted 2024-04-18 · Open, Classified

Recall details

Recalling firm

Draeger Medical, Inc.

Reason for recall

Unexpected shutdown while operating on battery power.

Action taken

Consignees were sent an Urgent Medical Device Recall notification by mail on 3/20/24. The notice informs consignees of the possibility of device shutdown with possible loss of ventilation, which consignees are instructed to either use an emergency ventilation bag or apply manual ventilation with the Perseus with the provided instructions. Consignees are to perform a battery test on all affected devices in their inventory per the provided instructions in the recall notification. If the tested unit(s) fails the battery test, consignees are to contact Drager Service Technical Support between 8:00 AM and 8:00 PM at 1-800-437-2437 (option 2, option 2, option 2) to arrange replacement of the device's battery. Consignees are also instructed to avoid short discharging/charging cycles of devices; if this cannot be accommodated device batteries are to be tested every three months. A supplemental IFU has been released to include the additional maintenance instructions outlined in the recall notification and can be requested from the firm. Consignees with any questions can contact Michael Kelhart between 8:00 AM to 4:30 PM EST at 267-664-1131 or mike.kelhart@draeger.com.

Root cause

Labeling design

Status

Open, Classified

Product code

BSZ

Quantity affected

16,841 units

Distribution

Domestic: Nationwide Distribution; Foreign: Angola, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-se- S, Bulgaria, Canada, Chili, China, Columbia, Cos

Date initiated

2024-03-20

Date posted

2024-04-18

Location

Telford, PA

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