Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography… recallZ-0005-2009 · Toshiba American Medical Systems Inc · initiated Sep 29, 2008
Terminated All recalls posted in September 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Toshiba American Medical Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation.
FDA root cause category: Software design
What the company is doing
Toshiba issued a letter entitled Important Electronic Product Radiation Warning, September 30, 2008, explaining the issue. The customers were requested to reply to the letter via fax-back form, and a Toshiba service representative would install the corrective action.
Recall details
- Recall number
- Z-0005-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 29, 2008
- Posted by the FDA
- Sep 28, 2009
- Recalling firm
- Toshiba American Medical Systems Inc
- Quantity
- 129
- Product code
- MQB
- FDA submissions
- K081624
- Distribution
- Nationwide
Product description
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Code information (models, lots, serial numbers)
Software version 3.40 or higher
Other devices under the same FDA submission
1 device cleared under K081624 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- INTERVENTIONAL ANGIOGRAPHY SYSTEM INFX-8000FCanon Inc. · Solid state x-ray imager (flat panel/digital imager)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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