RecallRadar

FDA Device recall Z-0836-2019

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

On 2019-02-20 the FDA classified a Class II recall of HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) by The Magstim, citing A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0836-2019
ClassificationClass II
Statusongoing
Initiated2018-10-25
Published2019-02-20
Last updated2026-09-13 11:55 UTC
CompanyThe Magstim
DistributionCA, MA, MN, PA, TX, VA, WA, WI

Product

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

Reason

A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm.

Identifiers

code_info
Product #: 5162-00 Serial #'s: 55308/001, 55308/002, 55310/001, 55310/002, 55446/001, 55446/002, 55447/001, 55447-002,…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0836-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.