Z-0836-2019Class II

HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)

Name: Z-0836-2019 HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
Creator: The Magstim Company Limited
Published: 2018-10-25
License: https://open.fda.gov/license/

Magstim Inc. / initiated 2018-10-25 / Open, Classified / root cause: manufacturing process

FDA source

The Magstim Company Limited began a recall of HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) on 2018-10-25. FDA classified it as Class II and gives the reason as "A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0836-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-10-25
Posted: 2019-02-14
Recalling firm: Magstim Inc.
Product: HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
Product code: OBP Transcranial Magnetic Stimulator
Reason for recall: A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On October 26, 2018, the firm sent URGENT FIELD SAFETY NOTICE, Medical Device Recall letters to their consignees to check their devices for this problem.
Quantity in commerce: 27 (including 2 demos)
Distribution: CA, MA, MN, PA, TX, VA, WI, and WA
Product codes and lots: Product #: 5162-00 Serial #'s: 55308/001, 55308/002, 55310/001, 55310/002, 55446/001, 55446/002, 55447/001, 55447-002, 55631-001, 55631-002, 55631-003, 55631-004, 55632/001, 55632/002, 55632/003, 55632/004, 55841/001, 55841-002, 55841-003, 55841-004, 55842/001, 55842/002, 55842/003, 55842/004, 55843-001, PLT00015/001 and PLT00015/002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0836-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0836-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-20	2019-02-14

Product code OBP

K180907Class IIHORIZON TMS Therapy SystemMagstim Company, Ltd. / cleared 2018-08-03

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)