Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
- Company
- Neurologica Corporation
- Recall Initiated
- January 12, 2018
- Terminated
- August 14, 2018
- Recall Number
- Z-1391-2018
- Quantity
- 16 units
- Firm Location
- Danvers, MA
Reason for Recall
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.
Distribution
US Distribution . Only one consignee was shipped 16 units of the affected device.
Lot / Code Info
Model Number GMR40. Serial numbers 00001 through 00016.
Root Cause
Device Design
Action Taken
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.
More recalls by Neurologica Corporation
GM60A. Digital Diagnostic Mobile X-Ray System.
Aug 22, 2024