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FDA Medical Device Recalls (openFDA)

Toshiba American Med Sys Inc: Toshiba Digital Radiography System Model DFP8000D

Recall number
Z-0532-06
Recalling firm
Toshiba American Med Sys Inc
Product
Toshiba Digital Radiography System Model DFP8000D
Status
Terminated
Initiated
2005-11-15
Posted
2006-02-23
Terminated
2007-07-12
Reason
In certain conditions the FOV of the lateral plane does not coincide with the X-ray exposed area, and consequently a part of the X-ray field may not be displayed in the magnification mode.
Root cause
Other
Action
An Advisory Letter will be sent to customers via certified mail. Corrected software will be provided at no charge. Customers can contact their local Toshiba Service person to schedule the software update.
Quantity
3
Distribution
CO, MI, & TX
Lot, serial or model codes
Serial #s W1C0552175, W1C0552181, W1C0562189
510(k) numbers
["K013608"]
PMA numbers
not on file
Product code
JAA
Firm FEI
2020563
Firm city
Tustin
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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