Drger Perseus A500 Anesthesia Workstation
Recall
- Recall Number
- Z-1512-2024
- Event Number
- 94269
- Firm
- Draeger Medical, Inc.
- FEI Number
- 2517967
- Product Code
- BSZ
- Status
- Open, Classified
- Root Cause
- Labeling design
- Initiated
- March 20, 2024
- Posted
- April 18, 2024
- Address
- 3135 Quarry Rd, Telford, PA, 18969-1042
Description
Drger Perseus A500 Anesthesia Workstation
Unexpected shutdown while operating on battery power.
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].
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.
16,841 units