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.
FDA Recall Z-1421-2009 · Posted 2009-05-27
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Recalling FirmNeuronetics, Inc.
Recall StatusTerminated
Product CodeOBP
Date Initiated2009-03-16
Date Terminated2009-05-29
Product Quantity3123 Units
Reason for Recall
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution to AZ, CA, DC, GA, FL, IL, MD, MI, MN, NH, NY, PA, RI, SC, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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