Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 12, 2018
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Canon Medical System, USA, INC. recalled DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD) - a moderate-severity action.
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD) was recalled by Canon Medical System, USA, INC. in September 12, 2018. Reason: It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message …. Check the official notice for the remedy. Verify recall #Z-2964-2018 with the FDA Devices before acting.
The recall
Canon Medical System, USA, INC. issued this moderate-severity FDA Devices recall-It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message ….
- Moderate
- severity level
- 43 units
- affected scope
- Class II
- classification
- September 12, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2964-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2964-2018) was formally reported on September 12, 2018, with the manufacturer initiating the action on April 18, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Canon Medical System, USA, INC. is listed as the recalling firm, operating out of Tustin, CA. Federal records list the affected scope as 43.
The documented reason for this recall is: It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not completed and there was no image. It a… Distribution data in the federal record shows the product reached: Domestic: AR, FL, GA, PA, IL, LA, MI, NC, NJ, NY, OH, TN, TX, UT, VT, WI, and WV Foreign: Australia, Canada, The Netherlands, South Korea, and Malaysia. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
43
Related Recalls
6
3 from same agency
Product description
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Reason for recall
It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not completed and there was no image. It also showed the OK button to reacquire image data form the FPD, and the Cancel button to cancel the reacquisition. When the operator selects the OK button, the same message window appears. The operator then repeated the same operation several times and finally selected the Cancel button to quit the reacquisition mode.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2964-2018 |
| Date reported | September 12, 2018 |
| Date initiated | April 18, 2018 |
| Recalling firm | Canon Medical System, USA, INC. |
| Firm location | Tustin, CA |
| Affected scope | 43 |
| Distribution | Domestic: AR, FL, GA, PA, IL, LA, MI, NC, NJ, NY, OH, TN, TX, UT, VT, WI, and WV Foreign: Australia, Canada, The Netherlands, South Korea, and Malaysia |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2964-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD). Recalled by Canon Medical System, USA, INC.. Units affected: 43.
Why was this product recalled? ▼
It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not completed and there was no image. It also showed the OK button to reacquire image data form the FPD, and the Cancel button to cancel the reacquisition. When the operator selects the OK button, the same message window appears. The operator then repeated the same operation several times and finally selected the Cancel button to quit the reacquisition mode.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2018. Severity: Moderate. Recall number: Z-2964-2018.
Where was the recalled product distributed? ▼
Distribution: Domestic: AR, FL, GA, PA, IL, LA, MI, NC, NJ, NY, OH, TN, TX, UT, VT, WI, and WV Foreign: Australia, Canada, The Netherlands, South Korea, and Malaysia.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2964-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 12, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.