Recall Z-0836-2019 ยท OBP Transcranial Magnetic Stimulator
The Magstim Company Limited
HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
| Date | Oct 25, 2018 |
| Status | Open, Classified |
| Reason | A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 27 (including 2 demos) |
| Distribution | CA, MA, MN, PA, TX, VA, WI, and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180907 | HORIZON TMS Therapy System Magstim Company, Ltd., Aug 3, 2018 |