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Open, Classified

Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation

FDA Recall Z-0506-2024 · Posted 2023-12-07

Recalling FirmLiberty Medical Solutions, LLC
Recall StatusOpen, Classified
Product CodeIPF
Date Initiated2023-11-03
Product Quantity473 units

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.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

US Nationwide distribution in the states of CT, FL, NC, NJ, NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093138MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003Shenzhen Dongdixin Technology Co., Ltd. · 2010-02-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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