Recall Z-3111-2017 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Toshiba American Medical Systems
Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and
| Date | Mar 23, 2017 |
| Status | Terminated |
| Reason | It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed " System Error (2063)" which required a reboot and loss of the image. |
| Root cause | Software design |
| Action | Toshiba America Medical Systems Inc. planned action to bring defect into compliance: 1.You will issue a Customer Notification Letter to make customers aware of the hazards, what measures will be taken to remedy the defect at no cost to the user, and how to safely use the equipment before corrections can be made. 2.You will install modified firmware on the systems to correct the defect and prevent recurrence. 3.You will provide progress reports on the effectiveness of the plan. If you have any questions, please feel free to contact your local Toshiba representative at (800) 421 |
| Quantity | 140 |
| Distribution | USA (nationwide) Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122842 | RADREX-I, SW V4.00 MODEL DRAD-3000E Toshiba America Medical Systems, In.C, Oct 9, 2012 |