MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B,
FDA device recall Z-0817-2016 · posted 2016-02-17 · Terminated
Recall details
- Recalling firm
- Nihon Kohden America Inc
- Reason for recall
- The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow.
- Action taken
- A customer notification letter dated 9/25/12 was sent to customers informing them of a potential malfunction of NIHON KOHDEN amplifier units, models JB-116B and JB-132B and Extension Unit MS-110B, used with the MEE-1000A Neuromaster Neural Function Measuring System. The letter informs the customers of the potential malfunction and that the probability that the malfunction occurs is extremely rare. The letter informs the customers of the preventive measure and the preventive corrective action. Customers are instructed to inform all potential users and operators of the Neural Function Measuring System MEE-1000A Neuromaster about the Corrective Action notice. Customers are instructed that NIHON KOHDEN technical support representative will contact them to arrange an update of their amplifier products.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GWF
- Quantity affected
- 477 units total (137 units in US)
- Distribution
- Worldwide distribution. US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.
- Date initiated
- 2012-01-19
- Date posted
- 2016-02-17
- Date terminated
- 2016-02-22
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEE-1000A NEUROMASTER (K051178) | Nihon Kohden America, Inc. | 2005-08-17 |