HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
- Recall Initiated
- October 25, 2018
- Recall Number
- Z-0836-2019
- Quantity
- 27 (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.
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.
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