Recall Z-1421-2009 ยท OBP Transcranial Magnetic Stimulator
Neuronetics, Inc.
NeuroStar TMS Therapy System/SenStar Treatment Link. The SenStar Treatment Link is a single use, disposable component of the NeuroStar TMS system, a non-invasive treatment for depression using highly focused, pulsed magnetic fields to stimulate function in targeted brain regions.
| Date | May 27, 2009 (initiated Mar 16, 2009) |
| Status | Terminated |
| Reason | SenStar Treatment Link may have an open circuit that during use with the NeuroStar TMS Therapy system may cause arcing and heat damage to the SenStar and/or treatment coil. Heating of the SenStar during use has a potential risk of minor scalp burn to patients. |
| Root cause | Process control |
| Action | Neuronetics Inc. notified consignees by telephone and sent a follow-up fax/letter dated March 19, 2009 titled "Urgent Product Recall Notification." The letter describes the issue and actions for consumers to take in response to the recall. Neuronetics will visit each customer in person to complete a "Returned Goods: SenStar Recall Inventory Form." Customer questions should be directed to Neuronetics Customer Service at 1-877-600-7555. |
| Quantity | 3123 Units |
| Distribution | Nationwide Distribution to AZ, CA, DC, GA, FL, IL, MD, MI, MN, NH, NY, PA, RI, SC, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083538 | NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 Neuronetics, Dec 16, 2008 |