Recall Z-0142-2027
- Recall number
- Z-0142-2027
- Event number
- 99812
- Firm
- Neuronetics, Inc.
- Firm FEI
- 3004824012
- Product code
- OBP
- Status
- Open, Classified
- Initiated
- 2026-08-24
- Posted
- 2026-10-09
- Root cause
- Nonconforming Material/Component
- 510(k) numbers
- K231926, K233621, K220177, K260560, K251125, K173441, K251119, K083538, K183376, K143531, K171967, K222230, K182700, K220127, K133408, K173540, K253098, K232235, K220819, K180907, K171902, K241518, K180313, K130233, K171481, K222171, K232639, K252032, K160309, K212723
Product#
NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1. NeuroStar 2.0 US; Part Number: 81-01315-000. 2. NeuroStar 3.0 US; Part Number: 81-02315-000. 3. NeuroStar 2.X to 3.2 Upgrade Kit; Part Number: 81-25000-100. 4. NeuroStar Upgrade Kit 3.0 US; Part Number: 81-35000-000. 5. NeuroStar Mobile Console 3.6, 120V, US; Part Number: 81-03315-000. 6. NeuroStar Mobile Console 3.7, 120V, US; Part Number: 81-04315-000. 7. NeuroStar Mobile Console 3.8, 120V, US; Part Number: 81-05315-000.
Reason for Recall#
Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.