BrightView, Gamma Camera System
Medical device recall Z-0677-2024. 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
- 359 US; 328 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, Gamma Camera System, Product Code 882480.
359 US; 328 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 4000002 4000262 4000681 4000218 4000413 4000312 4000389 4000678 4000484 4000288 4000393 4000393 4000494 4000354 4000699 4000515 4000679 4000479 4000689 4000082 4000373 4000471 4000545 4000331 4000038 4000002 4000060…
Every code shown here, 1,995 characters
No UDI Serial numbers 4000002 4000262 4000681 4000218 4000413 4000312 4000389 4000678 4000484 4000288 4000393 4000393 4000494 4000354 4000699 4000515 4000679 4000479 4000689 4000082 4000373 4000471 4000545 4000331 4000038 4000002 4000060 4000161 4000164 4000360 4000175 4000244 4000186 4000242 4000235 4000255 4000247 4000320 4000347 4000367 4000402 4000430 4000473 4000591 4000537 4000505 4000529 4000524 4000562 4000582 4000606 4000583 4000584 4000662 4000674 4000696 4000282 4000449 7135_11 4000410 4000651 4000652 4000665 4000688 4000350 4000044 4000061 4000081 4000065 4000002.75 4000180 4000224 4000321 4000229 4000280 4000378 4000559 4000552 4000298 4000009 4000190 4000184 4000305 4000303 4000324 4000411 4000516 4000554 4000566 4000576 4000614 4000612 4000627 4000669 4000033 4000070 4000091 4000123 4000102 4000008 4000202 4000166 4000276 4000287 4000364 4000455 4000498 4000497 4000012 4000213 4000197 4000353 4000335 4000418 4000510 4000436 4000454 4000469 4000500 4000491 4000518 4000472A 4000544 4000555 4000592 4000581 4000571 4000617 4000648 4000042 4000005 4000379 4000451 4000533 4000602 4000032 4000029 4000039 4000056 4000051 4000068 4000067 4000045 4000071 4000088 4000006 4000129 4000158 4000003 4000290 4000370 4000283 4000366 4000372 4000328 4000375 4000346 4000336 4000122 4000422 4000417 4000223 4000423 4000301 4000057 4000151 4000197_1 4000487 4000466 4000381 4000536 4000549 4000557 4000550 4000031 4000560 4000567 4000483 4000620 4000607 4000601 4000683 4000343 4000540 4000547 4000316 4000317 4000338 4000408 4000342 4000421 4000511 4000495 4000604 4000664 4000682 458008 4000041 4000030 4000167 4000203 4000407 4000341 4000647 4000125 4000279 4000216 4000269 4000254 4000208 4000345 4000415 4000672 4000286 4000294 4000395 4000390 4340005 4000199 4000281 4000211 4000096 4000348 4000613 4000655 4000419 4000464 4000463 4000462 4000638 4000156 4000049 4000047 4000412 4000268 4000273 4000228 4000382 4000297 4000337 4000169 4000447 4000442 4000488 4000595 4000693…
FDA’s list runs to 5,540 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 5,540 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.