CLASS I ONGOING Device recall · Reported 24 Apr 2024 · FDA Enforcement Report

Dr¿ger Perseus A500 Anesthesia Workstation recalled by Draeger Medical

Draeger Medical is recalling Dr¿ger Perseus A500 Anesthesia Workstation, distributed nationwide in the US. The recall was initiated on 20 Mar 2024 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesMaterial No. MX06000; UDI-DI: 04048675253600; All Serial No.

Quantity recalled16,841 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1512-2024
FDA event ID: 94269
Recalling firm: Draeger Medical, Telford, PA
Classification: Class I
Status: Ongoing
Recall initiated: 20 Mar 2024
FDA classified: 18 Apr 2024
Reported: 24 Apr 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

20 Mar 2024	Recall initiated by company
18 Apr 2024	Classified by FDA	+29 days
24 Apr 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Unexpected shutdown while operating on battery power.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Dr¿ger Perseus A500 Anesthesia Workstation

Where it was distributed

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.

Nationwide Georgia

Questions about this recall

Why was it recalled?

Unexpected shutdown while operating on battery power.

Which lots are affected?

Material No. MX06000; UDI-DI: 04048675253600; All Serial No.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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