FDA Recall
Open, Classified
HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
Recall: Z-0836-2019
·
Initiated October 25, 2018
Recall
- Recall Number
- Z-0836-2019
- Event Number
- 81489
- Firm
- The Magstim Company Limited Spring Gardens Whitland United Kingdom
- FEI Number
- 3002808356
- Product Code
- OBP
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 25, 2018
Description
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.
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.
Distribution
CA, MA, MN, PA, TX, VA, WI, and WA
Quantity
27 (including 2 demos)