Z-1512-2024Class I

Drger Perseus A500 Anesthesia Workstation

Name: Z-1512-2024 Drger Perseus A500 Anesthesia Workstation
Creator: Draeger Medical, Inc.
Published: 2024-03-20
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2024-03-20 / Open, Classified / root cause: labeling and UDI

FDA source

Draeger Medical, Inc. began a recall of Drger Perseus A500 Anesthesia Workstation on 2024-03-20. FDA classified it as Class I and gives the reason as "Unexpected shutdown while operating on battery power". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1512-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-03-20
Posted: 2024-04-18
Recalling firm: Draeger, Inc.
Product: Drger Perseus A500 Anesthesia Workstation
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: Unexpected shutdown while operating on battery power.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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 [email protected].
Quantity in commerce: 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, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, French Guiana, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Liechtenstein, Lithuania, Malaysia, Maldives, Mauritius, Mayotte, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, Uganda, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Vietnam.
Product codes and lots: Material No. MX06000; UDI-DI: 04048675253600; All Serial No.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1512-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1512-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-18

Product code BSZ

K133886Class IIPerseus A500Draeger Medical GmbH / cleared 2014-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)