BrightView XCT, Gamma Camera
Medical device recall Z-0679-2024. Published in FDA’s Enforcement Report on Jan 17, 2024.
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 Jan 17, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 135 US; 294 OUS 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?
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BrightView XCT, Gamma Camera, Product Code 882482
135 US; 294 OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
No UDI Serial numbers 7811_12 6000374 6000199 6000219 6000012 6000123 6000065 6000051 6000084 6000351 6000259 6000212 6000337 6000302 6000144 6000193 6000068 6000075 6000385 6000027 6000124 600009 6000176 6000260 6000298 6000189 6000040…
Every code shown here, 1,999 characters
No UDI Serial numbers 7811_12 6000374 6000199 6000219 6000012 6000123 6000065 6000051 6000084 6000351 6000259 6000212 6000337 6000302 6000144 6000193 6000068 6000075 6000385 6000027 6000124 600009 6000176 6000260 6000298 6000189 6000040 6000140 6000146 6000197 6000408 6000401 6000104 6000289 6000306 6000304 6000022 6000015 6000163 11000021 6000325 6000021 6000056 6000060 6000057 6000026 6000054 6000033 6000089 6000094 6000053 6000082 6000165 6000164 6000167 6000194 6000171 6000203 6000195 6000204 6000220 6000229 6000228 6000237 6000235 6000206 6000295 6000318 6000317 6000349 6000352 6000355 6000396 6000391 6000402 6000020 6000037 6000047 6000077 6000130 6000147 6000128 6000184 6000131 6000132 6000210 6000251 6000269 6000310 6000309 6000416 6000338 6000330 6000339 6000109 6000115 6000126 6000276 6000025 6000029 6000036 6000013 6000038 6000045 6000173 6000006 6000083 6000081 6000086 6000215 6000074 6000113 6000072 6000078 6000090 6000070 6000186 6000188 6000185 6000174 6000127 6000159 6000182 6000183 6000201 6000187 6000236 6000234 6000246 6000296 6000334 6000332 6000368 6000370 6000380 6000035 6000111 6000059 6000097 6000192 6000258 6000278 6000376 6000379 6000363 6000406 6000121 6000129 6000145 6000156 6000233 6000211 6000240 6000224 6000271 6000303 6000300 6000320 6000319 6000367 6000407 6000333 6000389 6000342 6000041 6000262 6000307 6000293 6000329 6000354 6000005 6000010 6000049 6000103 6000066 6000105 6000181 6000202 6000222 6000265 6000336 6000371 6000216 6000255 11000082 6000241 6000290 6000292 6000291 6000096 6000098 6000254 6000257 6000270 6000230 6000274 6000062 6000064 6000100 6000101 6000133 6000238 6000190 6000227 6000248 6000384 6000400 6000398 6000085 6000088 6000080 6000073 6000244 6000118 6000151 6000136 6000231 6000180 6000369 6000346 6000032 6000141 6000067 6000226 6000321 6000273 6000061 6000048 6000055 6000125 6000168 6000166 6000169 6000205 6000280 6000281 6000341 6000350 6000358 6000359 6000362 6000365 6000427 6000421 6000418 6000155 6000157…
FDA’s list runs to 3,457 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.
Domestic distribution nationwide. Foreign distribution worldwide.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Nov 30, 2023.
- FDA classified it on Jan 5, 2024.
- FDA’s Enforcement Report published it on Jan 17, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America, of Cambridge, MA.
- 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 3,457 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.