HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
This recall is currently active, issued October 25, 2018. It was issued by The Magstim Company Limited Spring Gardens Whitland United Kingdom.
- Recall Initiated
- October 25, 2018
- Recall Number
- Z-0836-2019
- Quantity
- 27 (including 2 demos)
- Official Source
- View on FDA website ↗
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
CA, MA, MN, PA, TX, VA, WI, and WA
Lot / Code Info
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
Root Cause
Nonconforming Material/Component
Action Taken
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.