Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0836-2019

October 25, 2018

Class II

Product summary

Firm
The Magstim Company Limited
Event
Event 81489
Status
Ongoing
Classification
Class II
Quantity
27 (including 2 demos)
Official record key
device-enforcement:Z-0836-2019

Official wording

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

Code information: 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

Distribution pattern: CA, MA, MN, PA, TX, VA, WI, and WA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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