Recall Z-1391-2018 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
NeuroLogica Corporation
Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
| Date | Jan 12, 2018 |
| Status | Terminated |
| Reason | While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit. |
| Root cause | Device Design |
| Action | A field safety notice was sent stating that the manufacturer, without charge, will remedy the defect. The notice stated that field upgrades would be performed by December 31, 2017. The notice provided instructions to end users and to distributors. For further questions, please call (978) 564-8503. |
| Quantity | 16 units |
| Distribution | US Distribution . Only one consignee was shipped 16 units of the affected device. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171085 | GMR40 Neurologica Corporation, A Subsidiary OF, May 11, 2017 |