foundmatterdb

Field reports on stuff that let you down

FDA device recallMedications· Neuronetics, Inc.

NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81…

Official notice from a government agency or its published feed.

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. Ne…
Reason: Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Worldwide distribution - US Nationwide and the countries of Japan and South Korea.

Hazard: Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280