Recall Z-0836-2019— The Magstim Company Limited

Name: FDA recall Z-0836-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-25

Class II · Ongoing

Class II FDA medical device recall by The Magstim Company Limited, initiated 2018-10-25. It names one FDA 510(k) clearance: K180907. 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..

Recalling firm: The Magstim Company Limited
Classification: Class II
Status: Ongoing
Initiated: 2018-10-25
Firm location: Whitland, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K180907 — HORIZON TMS Therapy SystemMagstim Company, Ltd.·cleared 2018-08-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.