FDAClass IApril 24, 2024

Dr¿ger Perseus A500 Anesthesia Workstation recall

Dr¿ger Perseus A500 Anesthesia Workstation

Why was Dr¿ger Perseus A500 Anesthesia Workstation recalled?

Unexpected shutdown while operating on battery power.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Dr¿ger Perseus A500 Anesthesia Workstation
Recalling firm
Draeger Medical, Inc.
Quantity
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.
Recall date
April 24, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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