The Recall Desk
HighFDA (Devices)·Z-1965-2020·Announced 2020-05-20

Magstim Horizon PSU Stim Interconnecting Cable Recalled for Potential Failure

The Magstim Company Limited is recalling 71 Horizon PSU Stim Interconnecting Cables because the high-voltage cable may fail. The device is used for treating Major Depressive Disorder.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device (electrical stimulation) with a potential for component failure, which poses a risk of harm, but the source text does not report any injuries or illnesses.

Plain-English summary

The Magstim Company Limited is recalling 71 units of the Horizon PSU Stim Interconnecting Cable. The recall was initiated after it was identified that there is a potential for the Stim Interconnecting high Voltage Cable, located at the rear of the Rapid2 and Horizon power supply unit, to fail.

The Horizon device is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. The affected product is identified by Product Number 5188-00.

The recall covers worldwide distribution, including US nationwide distribution in the states of AL, AR, CA, CT, TN, IL, MN, MT, NC, NJ, NY, PA, SC, TX, and WA, as well as distribution in Cyprus, China, Iran, Saudi Arabia, UK, Italy, Malaysia, Spain, Taiwan, Vietnam, Australia, Japan, Turkey, France, and Israel. The source text does not specify specific actions for consumers or patients to take.

The recalled product

Product
Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Manufacturer
The Magstim Company Limited
Category
Medical Device — Neuromodulation
Hazard
Affected units
71

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product Number: 5188-00

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 2 recalled by The Magstim Company Limited under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · The Magstim Company Limited

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