Recall Z-2249-2024 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Megadyne Medical Products, Inc.
Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No
| Date | Jul 3, 2024 (initiated Jun 17, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | An URGENT MEDICAL DEVICE CORRECTION letter, dated 6/17/24, was mailed to consignees. Consignees are instructed to share the recall notification with all users of affected devices and confirm their understanding, post a copy of the communication for user awareness, and forward the recall notification to any facility to which product was shipped. The notification reads that Mega Soft and Mega 2000 devices are only to be used for patients 12 years old. The notification also reminds consignees to follow proper cleaning, placement, and setup steps. Consignees are asked to complete and return the pr |
| Quantity | 2584 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021077 | MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD Megadyne Medical Products, Inc., Apr 17, 2002 |