Recall Z-3111-2017— Toshiba American Medical Systems

Name: FDA recall Z-3111-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-23

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems, initiated 2017-03-23, terminated 2020-10-23. It names one FDA 510(k) clearance: K122842. 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.. 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..

Recalling firm: Toshiba American Medical Systems
Classification: Class II
Status: Terminated
Initiated: 2017-03-23
Terminated: 2020-10-23
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K122842 — RADREX-I, SW V4.00 MODEL DRAD-3000EToshiba America Medical Systems, In.C·cleared 2012-10-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.