Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs. (11.4Kg), 91cm Long x 51cm Wide Component: No
Reported: July 10, 2024 Initiated: June 17, 2024 #Z-2248-2024
Product Description
Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs. (11.4Kg), 91cm Long x 51cm Wide Component: No
Reason for Recall
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Details
- Recalling Firm
- Megadyne Medical Products, Inc.
- Units Affected
- 259 units
- Distribution
- Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, GERMANY, GREECE, INDIA, ITALY, NETHERLANDS, NORWAY, JAPAN, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, THAILAND, TURKEY, UNITED KINGDOM, UNITED STATES,
- Location
- Blue Ash, OH
Frequently Asked Questions
What product was recalled? ▼
Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs. (11.4Kg), 91cm Long x 51cm Wide Component: No. Recalled by Megadyne Medical Products, Inc.. Units affected: 259 units.
Why was this product recalled? ▼
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2024. Severity: Critical. Recall number: Z-2248-2024.
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