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Drger Perseus A500 Anesthesia Workstation recallZ-1512-2024 · Draeger Medical, Inc. · initiated Mar 20, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Draeger Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Unexpected shutdown while operating on battery power.

FDA root cause category: Labeling design

What the company is doing

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].

Recall details

Recall number
Z-1512-2024
Status
Open, Classified
Initiated by the company
Mar 20, 2024
Posted by the FDA
Apr 18, 2024
Recalling firm
Draeger Medical, Inc.
Quantity
16,841 units
Product code
BSZ
FDA submissions
K133886
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 description

Drger Perseus A500 Anesthesia Workstation

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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