Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 25, 2017
Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications ca
During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Toshiba American Medical Systems Inc recalled Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to … - a moderate-severity action.
Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to … was recalled by Toshiba American Medical Systems Inc in October 25, 2017. Reason: During an examination images were displayed on the live monitor,but the images were not displayed on the syst…. Check the official notice for the remedy. Verify recall #Z-0012-2018 with the FDA Devices before acting.
The recall
Toshiba American Medical Systems Inc issued this moderate-severity FDA Devices recall-During an examination images were displayed on the live monitor,but the images were not displayed on the syst….
- Moderate
- severity level
- Class II
- classification
- October 25, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0012-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0012-2018) was formally reported on October 25, 2017, with the manufacturer initiating the action on September 12, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Toshiba American Medical Systems Inc is listed as the recalling firm, operating out of Tustin, CA. Federal records list the affected scope as US - 96.
The documented reason for this recall is: During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk. Distribution data in the federal record shows the product reached: USA (nationwide) Distribution. 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 - 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 - 40,422 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
US - 96
Related Recalls
6
0 from same agency
Product description
Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.
Reason for recall
During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0012-2018 |
| Date reported | October 25, 2017 |
| Date initiated | September 12, 2017 |
| Recalling firm | Toshiba American Medical Systems Inc |
| Firm location | Tustin, CA |
| Affected scope | US - 96 |
| Distribution | USA (nationwide) Distribution |
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-0012-2018) 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? ▼
Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.. Recalled by Toshiba American Medical Systems Inc. Units affected: US - 96.
Why was this product recalled? ▼
During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 25, 2017. Severity: Moderate. Recall number: Z-0012-2018.
Where was the recalled product distributed? ▼
Distribution: USA (nationwide) Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0012-2018) 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 October 25, 2017. 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.