Recall Z-0506-2024 ยท IPF Stimulator, Muscle, Powered
Liberty Medical Solutions, LLC
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
| Date | Dec 7, 2023 (initiated Nov 3, 2023) |
| Status | Open, Classified |
| Reason | The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications. |
| Root cause | Error in labeling |
| Action | Liberty Medical Solutions, LLC issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/03/2023 via US Mail. The notice explained the problem and provided an updated instruction manual. |
| Quantity | 473 units |
| Distribution | US Nationwide distribution in the states of CT, FL, NC, NJ, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093138 | MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003 Shenzhen Dongdixin Technology Co., Ltd., Feb 12, 2010 |