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Recall Observatory FDA recall evidence

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

May 08, 2024

Class I

Product summary

Firm
Megadyne Medical Products, Inc.
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

    reason.no_named_rule · v1.0.0

    Reports of patient burns.