Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital…
Medical device recall Z-1537-2015. Published in FDA’s Enforcement Report on May 6, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 6, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 825 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are 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
825 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 120001 120002 120003 120004 120005 120006 120007 120008 120009 120010 120011 120012 120013 120014 120015 120016 120017 120018 120019 120020 120021 120022 120023 120024 120025 120026 120027 120028 120029 120030 120031 120032…
Every code shown here, 1,997 characters
Serial Numbers: 120001 120002 120003 120004 120005 120006 120007 120008 120009 120010 120011 120012 120013 120014 120015 120016 120017 120018 120019 120020 120021 120022 120023 120024 120025 120026 120027 120028 120029 120030 120031 120032 120033 120034 120035 120036 120037 120038 120039 120040 120041 120042 120043 120044 120045 120046 120047 120048 120049 120050 120051 120052 120053 120054 120055 120056 120057 120058 120060 120061 120062 120063 120064 120065 120066 120067 120068 120069 120070 120071 120072 120073 120074 120075 120076 120077 120078 120079 120080 120081 120082 120083 120084 120085 120086 120087 120088 120089 120090 120091 120092 120093 120094 120095 120096 120097 120098 120099 120100 120101 120102 120103 120104 120105 120106 120107 120108 120109 120110 120111 120112 120113 120114 120115 120116 120117 120118 120119 120120 120121 120122 120123 120124 120125 120126 120128 120129 120132 120133 120134 120135 120136 120137 120139 120140 120141 120142 120143 120144 120145 120146 120147 120148 120149 120150 120151 120152 120153 120154 120155 120156 120157 120158 120159 120160 120161 120162 120163 120164 120165 120166 120167 120168 120169 120170 120171 120172 120173 120174 120175 120176 120177 120178 120179 120180 120181 120182 120183 120184 120185 120186 120187 120188 120189 120190 120191 120192 120193 120194 120195 120196 120197 120198 120199 120200 120201 120202 120203 120204 120205 120208 120209 120210 120211 120212 120213 120215 120216 120217 120218 120219 120220 120221 120222 120223 120224 120225 120226 120227 120228 120229 120230 120231 120232 120233 120234 120235 120236 120237 120238 120239 120240 120241 120242 120243 120244 120245 120246 120247 120248 120249 120250 120251 120252 120253 120254 120255 120256 120257 120258 120259 120260 120261 120262 120263 120264 120265 120266 120267 120268 120269 120270 120271 120272 120273 120274 120275 120276 120277 120278 120279 120280 120281 120282 120283 120284 120285 120286 120287 120288 120289 120290 120291…
FDA’s list runs to 5,734 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide Distribution
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 6, 2015.
- FDA classified it on Apr 27, 2015.
- FDA’s Enforcement Report published it on May 6, 2015.
- FDA terminated it on Nov 23, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GA Industries, of Palos Verdes Estates, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,734 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.