NeuroStar TMS Therapy System/SenStar Treatment Link. The SenStar Treatment Link is a single use, disposable component of
FDA device recall Z-1421-2009 · posted 2009-05-27 · Terminated
Recall details
- Recalling firm
- Neuronetics, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- OBP
- Quantity affected
- 3123 Units
- Distribution
- Nationwide Distribution to AZ, CA, DC, GA, FL, IL, MD, MI, MN, NH, NY, PA, RI, SC, and WA.
- Date initiated
- 2009-03-16
- Date posted
- 2009-05-27
- Date terminated
- 2009-05-29
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 (K083538) | Neuronetics | 2008-12-16 |