BrightView SPECT
Medical device recall Z-2009-2019. Published in FDA’s Enforcement Report on Jul 31, 2019.
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 Jul 31, 2019. 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
- 696 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?
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BrightView SPECT, Model Number 882480
696, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 4000665 4000410 4000652 4000651 4000350 4000688 4000224 4000065 4000321 4000002.75 4000044 4000081 4000061 4000180 4000298 4000280 4000229 4000262 4000552 4000378 4000559 4000324 4000576 4000184 4000190 4000516 4000554…
Every code shown here, 1,994 characters
Serial Numbers: 4000665 4000410 4000652 4000651 4000350 4000688 4000224 4000065 4000321 4000002.75 4000044 4000081 4000061 4000180 4000298 4000280 4000229 4000262 4000552 4000378 4000559 4000324 4000576 4000184 4000190 4000516 4000554 4000627 4000566 4000303 4000614 4000411 4000669 4000009 4000305 4000612 4000681 4000301-1 4000202 4000008 4000218 4000166 4000033 4000455 4000287 4000091 4000497 4000498 4000102 4000276 4000123 4000364 4000070 4000699 40000699 4000213 4000012 4000413 4000335 4000197 4000571 4000436 4000648 4000617 4000581 4000500 4000544 4000592 4000491 4000510 4000518 4000472A 4000555 4000454 4000418 4000353 4000469 4000005 4000042 4000379 4000451 4000533 4000602 4000343 4000540 4000547 4000682 4000317 4000338 4000316 4000342 4000408 4000421 4000495 4000511 4000664 4000604 458008 4000647 4000341 4000328 4000375 4000483 4000346 4000683 4000550 4000487 4000039 4000601 4000067 4000068 4000301 4000031 4000560 4000283 4000045 4000129 4000032 4000312 4000422 4000366 4000372 4000381 4000051 4000003 4000071 4000557 4000336 4000620 4000567 4000678 4000057 4000057-OLD 4000006 4000423 4000223 4000056 4000197_1 4000122 4000549 4000417 4000466 4000151 4000389 4000536 4000370 4000088 4000290 4000158 4000029 4000607 4000672 4000286 4000395 4000294 4000348 4000613 4000655 4000390 4000419 4000462 4000463 4000464 4000638 422 281 199 288 4000096 4000281 4000288 4000484 4340005 97001 4000273 4000268 4000382 4000169 4000447 4000595 4000692 4000693 4000228 4000442 4000047 4000049 4000156 4000412 4000297 4000488 4000337 4000600 4000585 4000109 4000115 4000504 4000631 4000494 4000356 4000503 4000194 4000386 4000179 4000401 4000385 4000397 4000667 4000121 4000257 4000398 4000400 4000105 4000333 4000339 4000107 4000227 4000233 4000173 4000168 4000256 4000698 4000126 4000154 4000399 4000072 4000237 4000493 4000354 4000296 4000272 4000478 4340004 4000643 4000694 4000376 4000219 4000243 4000437 4000416 4000485 4000035 4000645 4000551 4000427 4000548 4000691 6000046 4000475…
FDA’s list runs to 5,598 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 Jun 10, 2019.
- FDA classified it on Jul 22, 2019.
- FDA’s Enforcement Report published it on Jul 31, 2019.
- FDA terminated it on Jul 24, 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 5,598 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
-
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.