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Terminated

Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device

FDA Recall Z-0533-06 · Posted 2006-03-29

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2006-02-23
Date Terminated2012-02-29
Product Quantity5

Reason for Recall

When the error condition occurs the x-ray exposures will terminate immediately. The digital system (EPS-Plus/ADR-1000A) will immediately stop acquiring images or will continue to acquire blank images. The remote console will lock-up upon release of the hand switch. The operator must reboot the system. This will result in the loss of the images acquired during the contrast portion of the study.

Firm Action

Recall letter to be sent to to customers of affected devices beginning February 23, 2006. Corrected software to be issued by Toshiba America Medical Systems Inc, for all affected devices.

Root Cause

Other

Distribution Pattern

Nationwide to AZ, CA, FL, MT, & PA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961307SMART SPOTCmt Medical Technologies, Ltd. · 1996-07-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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