Class 1 Device Recall Draeger Perseus A500

• Date Initiated by Firm: March 20, 2024
• Date Posted: April 18, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1512-2024
• Recall Event ID: 94269
• 510(K)Number: K133886
• Product Classification: Gas-machine, anesthesia - Product Code BSZ
• Product: Dr¿ger Perseus A500 Anesthesia Workstation
• Code Information: Material No. MX06000; UDI-DI: 04048675253600; All Serial No.
• Recalling Firm/ Manufacturer: Draeger Medical, Inc.; 3135 Quarry Rd; Telford PA 18969-1042
• For Additional Information Contact: Mike Kelhart; 267-664-1131
• Manufacturer Reason for Recall: Unexpected shutdown while operating on battery power.
• FDA Determined 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 mike.kelhart@draeger.com.
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = BSZ and Original Applicant = DRAEGER MEDICAL GMBH