| Date Initiated by Firm | March 23, 2017 |
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| Create Date | September 11, 2017 |
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| Recall Status1 |
Terminated 3 on October 23, 2020 |
| Recall Number | Z-3111-2017 |
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| Recall Event ID |
77888 |
| 510(K)Number | K122842 |
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| Product Classification |
Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
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| Product | 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 trans mission/ output of images to external devices. |
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| Code Information |
Serial No. W8B1572022 |
Recalling Firm/
Manufacturer |
Toshiba American Medical Systems
2441 Michelle Dr
Tustin CA 92780-7047
|
| For Additional Information Contact |
800-421-1968 |
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Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Software design |
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| 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) 421-1968. |
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| Quantity in Commerce | 140 |
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| Distribution | USA (nationwide) Distribution |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = MQB
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