Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: electrical-failure
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 →

Same manufacturer · The Magstim Company Limited

See all →

Moderate
Magstim Recalls Neurosign 100 Intraoperative Nerve Monitors for Voltage Configuration Error
FDA (Devices) · 2021-01-27
High
Magstim Recalls Neurosign V4 Intraoperative Nerve Monitors Due to Cable Damage Risk
FDA (Devices) · 2020-09-02
High
Magstim Recalls Rapid2 Stim Interconnecting Cables Due to Potential Failure
FDA (Devices) · 2020-05-20
High
Magstim HORIZON Ez Arm Recalled for Protruding Stainless-Steel Cable Strand
FDA (Devices) · 2019-02-20
Low
Magstim Rapid Therapy System Recalled for Missing User Manuals
FDA (Devices) · 2018-04-18

Same hazard · electrical failure