Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
FDA device recall Z-0506-2024 · posted 2023-12-07 · Open, Classified
Recall details
- Recalling firm
- Liberty Medical Solutions, LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- IPF
- Quantity affected
- 473 units
- Distribution
- US Nationwide distribution in the states of CT, FL, NC, NJ, NY.
- Date initiated
- 2023-11-03
- Date posted
- 2023-12-07
- Location
- Tampa, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003 (K093138) | Shenzhen Dongdixin Technology Co., Ltd. | 2010-02-12 |