Z-1965-2020Class II

Horizon PSU Stim Interconnecting Cable -

Name: Z-1965-2020 Horizon PSU Stim Interconnecting Cable -
Creator: The Magstim Company Limited
Published: 2020-03-23
License: https://open.fda.gov/license/

Magstim Inc. / initiated 2020-03-23 / Terminated / root cause: manufacturing process

FDA source

The Magstim Company Limited began a recall of Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed... on 2020-03-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1965-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-23
Posted: 2020-05-13
Terminated: 2024-09-20
Recalling firm: Magstim Inc.
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.
Product code: OBP Transcranial Magnetic Stimulator
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The Magstim Company Ltd notified customers on about 3/23/2020 via URGENT FIELD SAFETY NOTICE Medical Device Recall letter. The letter instructed customers to identify all affected products at their facility, raise awareness to all those who need to be aware within their organization, notify customers if the product was further distributed, and complete and return the provided acknowledgement form, so Magstim Company can contact them to arrange replacement of the cable. Once customers have returned the acknowledgement form, Magstim Company will arrange for a new cable to be sent to you or your technical personnel. This will be accompanied by instructions on how to install the new cable. Magstim Technical Service Team can guide you through the installation via telephone or video call. This to limit transmission during the current pandemic COVID-19.
Quantity in commerce: 71 units total
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, CA, CT, TN, IL, MN, MT, NC, NJ, NY, PA, SC, TX, WA, and the countries of Cyprus, China, Iran, Saudi Arabia, UK, Italy, Malaysia, Spain, Taiwan, Vietnam, Australia, Japan, Turkey, France and Israel.
Product codes and lots: Product Number: 5188-00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1965-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1965-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-13
Z-1966-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-13

Product code OBP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)