Device recall

Z-1421-2009: NeuroStar TMS Therapy System/SenStar Treatment Link. The SenStar Treatment Link…

FDA device recall · Class II · Neuronetics, Inc.

Key facts

Recall number (Z-number) Z-1421-2009
Recall event 51703
Product 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.
Product code OBP
Recalling firm Neuronetics, Inc.
Recall class Class II
Status Terminated
Termination date May 29, 2009
510(k) numbers K061053
FEI number 3004824012

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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