BrightView XCT
Medical device recall Z-1186-2017. Published in FDA’s Enforcement Report on Feb 22, 2017.
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 Feb 22, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 27 states named in where it went
- 425 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?
The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BrightView XCT
425, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
6000013 6000025 6000029 6000036 6000038 6000045 6000051 6000065 6000006 6000070 6000074 6000072 6000078 6000081 6000083 6000084 6000086 6000090 6000113 6000127 6000173 6000174 6000185 6000182 6000188 6000183 6000187 6000186 6000201 6000215…
Every code shown here, 1,994 characters
6000013 6000025 6000029 6000036 6000038 6000045 6000051 6000065 6000006 6000070 6000074 6000072 6000078 6000081 6000083 6000084 6000086 6000090 6000113 6000127 6000173 6000174 6000185 6000182 6000188 6000183 6000187 6000186 6000201 6000215 6000236 6000234 6000246 6000296 6000332 6000334 6000351 6000368 6000370 6000380 6000012 6000152 6340009 6000011 6000024 6000175 6000031 6000253 6000042 6000052 6000030 6000002 6000004 6000069 6000076 6000142 6000004A 6000122 6000016 6000158 6000189 6000093 6000005 6000095 6000092 6000022 6000035 6000019 6000023 6000010 6000111 6000040 6000056 6000060 6000057 6000026 6000054 6000033 6000028 6000114 6000003 6000049 6000059 6000110 6000020 6000062 6000058 6000162 6000018 6000043 6000064 6000071 6000027 6000037 6000085 6000047 6000017 6000015 6000063 6000061 6000048 6000055 6000091 6000044 6000106 6000100 6000067 6000102 6000096 6000286 6000103 6000088 6000107 6000068 6000041 6000050 6000104 6000077 6000066 6000089 6000094 6000099 6000130 6000117 6000080 6000097 6000087 6000134 6000073 6000079 6000053 6000105 6000244 6000101 6000116 6000218 6000121 6000148 6000108 6000138 6000143 6000098 6000150 6000082 6000118 6000123 6000120 6000277 6000147 6000144 6000128 6000119 6000109 6000112 6000208 6000115 6000125 6000209 6000288 6000139 6000160 6000159 6000140 6000129 6000184 6000145 6000146 6000161 6340008 6000141 6000131 6000135 6000132 6000361 6000151 6000133 6000238 6000191 6000155 6000149 6000153 6000156 6000163 6000136 6000254 6000257 6000177 6000154 6000270 6000225 6000170 6000196 6000126 6000157 11000021 6000165 6000164 6000167 6000190 6000168 6000166 6000169 6000172 6000178 6000405 6000353 6000214 6000198 6000197 6000231 6000180 6000193 6000192 6000213 6000176 6340010 6000179 6000194 6000171 6000203 6000195 6000199 6000204 6000233 6000212 6000200 6000181 6000360 6000202 6000217 6000412 6000205 6000210 6000227 6000272 6000211 6000230 6000219 6000220 6000229 6000228 6000237 6000235 6000207 6000206 6000250 6000222 6000226 6000046…
FDA’s list runs to 3,420 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.
Products were distributed in the following states: AZ, CA, CO, DC, DE, FL, GA, IL, LA, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, TX, VT, WA, & WI. Product was distributed internationally to the following countries: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Gabon, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russian Federation, Saudia Arabia, Slovakia, South AFrica, Apain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.
The states and territories these words name
27 states and territories.
Every one of them
- Arizona
- California
- Colorado
- District of Columbia
- Delaware
- Florida
- Georgia
- Illinois
- Louisiana
- Massachusetts
- Maryland
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- New Jersey
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Texas
- Vermont
- Washington
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Dec 23, 2016.
- FDA classified it on Feb 10, 2017.
- FDA’s Enforcement Report published it on Feb 22, 2017.
- FDA terminated it on Jul 2, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Medical Systems (Cleveland) Inc, of Cleveland, OH.
- 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 3,420 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.