FDAClass IIFebruary 20, 2019

Horizon Ez Arm recall

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

Why was Horizon Ez Arm recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
Recalling firm
The Magstim Company Limited
Quantity
27 (including 2 demos)
Distribution
CA, MA, MN, PA, TX, VA, WI, and WA
Recall date
February 20, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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