Recall Z-0817-2016 ยท GWF Stimulator, Electrical, Evoked Response
Nihon Kohden America Inc
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
| Date | Feb 17, 2016 (initiated Jan 19, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 Measuri |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051178 | MEE-1000A NEUROMASTER Nihon Kohden America, Inc., Aug 17, 2005 |