HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
FDA Recall Z-0836-2019 · Posted None
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Recalling FirmThe Magstim Company Limited
Recall StatusOpen, Classified
Product CodeOBP
Date Initiated2018-10-25
Product Quantity27 (including 2 demos)
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
CA, MA, MN, PA, TX, VA, WI, and WA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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