BrightView XCT
Medical device recall Z-0511-2018. Published in FDA’s Enforcement Report on Feb 14, 2018.
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 14, 2018. 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
- 1387 in total 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?
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.
1387 in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Brightview XCT Model 882482 Serial Numbers : 6000241 6000290 6000291 6000292 6000306 6000289 6000304 6000374 6000237 6000317 6000235 6000318 6000167 6000194 6000229 6000391 6000352 6000220 6000054 6000060 6000195 6000204 6000206 6000295…
Every code shown here, 1,998 characters
Brightview XCT Model 882482 Serial Numbers : 6000241 6000290 6000291 6000292 6000306 6000289 6000304 6000374 6000237 6000317 6000235 6000318 6000167 6000194 6000229 6000391 6000352 6000220 6000054 6000060 6000195 6000204 6000206 6000295 6000203 6000043 6000082 6000402 6000056 6000026 6000228 6000171 6000355 6000089 6000033 6000053 6000094 6000093 6000165 6000199 6000349 6000219 6000396 6000163 11000021 6000325 6000022 6000015 6000020 6000047 6000130 6000184 6000330 6000147 6000123 6000077 6000128 6000251 6000066 6000131 6000132 6000338 6000310 6000309 6000269 6000210 6000012 6000037 6000416 6000339 6000276 6000115 6000126 6000109 6000113 6000051 6000351 6000201 6000332 6000013 6000368 6000370 6000215 6000127 6000236 6000006 6000038 6000045 6000065 6000173 6000084 6000187 6000186 6000070 6000183 6000185 6000188 6000090 6000072 6000078 6000182 6000074 6000036 6000334 6000380 6000296 6000246 6000081 6000083 6000086 6000025 6000029 6000174 6000234 6000363 6000406 6000389 6000233 6000224 6000121 6000145 6000342 6000156 6000300 6000211 6000212 6000303 6000333 6000367 6000407 6000320 6000240 6000129 6000319 6000271 6000041 6000262 6000293 6000307 6000329 6000354 11000082 6000255 6000216 6000337 6000274 6000227 6000256 6000384 6000064 6000398 6000101 6000133 6000238 6000400 6000062 6000222 6000100 6000190 6000103 6000265 6000336 6000181 6000010 6000105 6000371 6000032 6000346 6000226 6000321 6000141 6000067 6000068 6000075 6000273 6000350 6000281 6000168 6000359 6000061 6000427 6000166 6000169 6000048 6000055 6000362 6000358 6000125 6000280 6000418 6000341 6000421 6000205 6000365 6000157 6000326 6000155 6000249 6000044 6000120 6000315 6000385 6000299 6000027 6000079 6000193 6000099 600009 6000124 6000017 6000139 6000247 6000426 6000046 6000102 6340008 6000176 6000347 6000410 6000414 6000305 6340010 6000039 6000260 6000267 6000392 6000343 6000268 6000223 6000323 6000294 6000428 6000264 6000252 6000413 6000154 6000242 6000243 6000298 6000314 6000423 6000424 6000425 6000138…
FDA’s list runs to 3,497 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.
Worldwide Distribution - US Nationwide
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.
The words say it went outside the United States too.
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 Dec 15, 2017.
- FDA classified it on Feb 2, 2018.
- FDA’s Enforcement Report published it on Feb 14, 2018.
- FDA terminated it on Apr 10, 2020.
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 3,497 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.