Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 29, 2019
DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may
The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
KaVo Dental Technologies LLC recalled DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is… - a moderate-severity action.
DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is… was recalled by KaVo Dental Technologies LLC in May 29, 2019. Reason: The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in …. Check the official notice for the remedy. Verify recall #Z-1387-2019 with the FDA Devices before acting.
The recall
KaVo Dental Technologies LLC issued this moderate-severity FDA Devices recall-The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in ….
- Moderate
- severity level
- 211 units
- affected scope
- Class II
- classification
- May 29, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1387-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1387-2019) was formally reported on May 29, 2019, with the manufacturer initiating the action on April 29, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. KaVo Dental Technologies LLC is listed as the recalling firm, operating out of Charlotte, NC. Federal records list the affected scope as 211 devices.
The documented reason for this recall is: The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide to AL, AR, AZ, CA, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, OH, OK, PA, TN, TX, VA, WA, WI, WV and internationally to Canada.. 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
211 devices
Related Recalls
6
6 from same agency
Product description
DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
Reason for recall
The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1387-2019 |
| Date reported | May 29, 2019 |
| Date initiated | April 29, 2019 |
| Recalling firm | KaVo Dental Technologies LLC |
| Firm location | Charlotte, NC |
| Affected scope | 211 devices |
| Distribution | Worldwide Distribution - US Nationwide to AL, AR, AZ, CA, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, OH, OK, PA, TN, TX, VA, WA, WI, WV and internationally to Canada. |
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-1387-2019) 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? ▼
DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.. Recalled by KaVo Dental Technologies LLC. Units affected: 211 devices.
Why was this product recalled? ▼
The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2019. Severity: Moderate. Recall number: Z-1387-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide to AL, AR, AZ, CA, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, OH, OK, PA, TN, TX, VA, WA, WI, WV and internationally to Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1387-2019) 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.
Nearby Recalls in This Category
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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 May 29, 2019. 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 August 2026.