Device product
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.
Z-1920-2024
Product summary
- Event
- Event 94544
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1270
- Official record key
device-enforcement:Z-1920-2024
Official wording
Reason: Reports of patient burns.
Code information: Model Number: 0840; UDI-DI: 10614559103395; Lot Number: All distributed lot numbers.
Distribution pattern: Worldwide distribution. US nationwide including Puerto Rico; Australia, Austria, Bahrain, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, the Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
Derived failure modes
-
Unknown
Reports of patient burns.