Z-3111-2017Class II

Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with...

Name: Z-3111-2017 Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with...
Creator: Toshiba American Medical Systems
Published: 2017-03-23
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2017-03-23 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems began a recall of 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... on 2017-03-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-3111-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-23
Posted: 2017-09-11
Terminated: 2020-10-23
Recalling firm: Canon Medical Systems USA, Inc.
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.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
Root cause tag: software
FDA 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) 421-1968.
Quantity in commerce: 140
Distribution: USA (nationwide) Distribution
Product codes and lots: Serial No. W8B1572022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3111-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3111-2017	Class II	Terminated	FDA Mandated	2017-09-20	2017-09-11

Product code MQB

K122842Class IIRadrex-I, Sw V4.00 Model Drad-3000EToshiba America Medical Systems, In.C / cleared 2012-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)