Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 6, 2015
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression ove
GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not submitted for approval to the FDA prior to product release.
Ga Industries recalled Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for deca… - a moderate-severity action.
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for deca… was recalled by Ga Industries in May 6, 2015. Reason: GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not…. Check the official notice for the remedy. Verify recall #Z-1537-2015 with the FDA Devices before acting.
The recall
Ga Industries issued this moderate-severity FDA Devices recall-GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not….
- Moderate
- severity level
- 825 units
- affected scope
- Class II
- classification
- May 6, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1537-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1537-2015) was formally reported on May 6, 2015, with the manufacturer initiating the action on April 6, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Ga Industries is listed as the recalling firm, operating out of Palos Verdes Estates, CA. Federal records list the affected scope as 825 units.
The documented reason for this recall is: GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not submitted for approval to the FDA prior to product release. Distribution data in the federal record shows the product reached: US 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, 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
825 units
Related Recalls
6
3 from same agency
Product description
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
Reason for recall
GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not submitted for approval to the FDA prior to product release.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1537-2015 |
| Date reported | May 6, 2015 |
| Date initiated | April 6, 2015 |
| Recalling firm | Ga Industries |
| Firm location | Palos Verdes Estates, CA |
| Affected scope | 825 units |
| Distribution | US 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-1537-2015) 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? ▼
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool. Recalled by Ga Industries. Units affected: 825 units.
Why was this product recalled? ▼
GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not submitted for approval to the FDA prior to product release.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2015. Severity: Moderate. Recall number: Z-1537-2015.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1537-2015) 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 May 6, 2015. 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.