Z-0836-2019 Class II Ongoing
FDA device recall Z-0836-2019 was initiated by The Magstim Company Limited on October 25, 2018 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 27 (including 2 demos).
Recall Details
- Product Type
- Devices
- Report Date
- February 20, 2019
- Initiation Date
- October 25, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 (including 2 demos)
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.
Distribution Pattern
CA, MA, MN, PA, TX, VA, WI, and WA
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