Incisive CT-Computed Tomography X-Ray System
Medical device recall Z-2258-2023. Published in FDA’s Enforcement Report on Aug 9, 2023.
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 Aug 9, 2023. 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
- 36 US; 610 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?
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Incisive CT-Computed Tomography X-Ray System Model: 728143
36 US; 610 OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: (01) 00884838085015 (21) + Serial number Serial Numbers: 33001 33002 33003 33005 33006 33007 33008 33009 33010 33011 33012 33013 33015 33016 33017 33019 33020 33024 33025 33031 33033 33034 33035 33037 33038 33039 33041 33042 33045…
Every code shown here, 1,999 characters
UDI-DI: (01) 00884838085015 (21) + Serial number Serial Numbers: 33001 33002 33003 33005 33006 33007 33008 33009 33010 33011 33012 33013 33015 33016 33017 33019 33020 33024 33025 33031 33033 33034 33035 33037 33038 33039 33041 33042 33045 33046 33047 33049 500252 500255 500282 500301 OUS: System Serial Number 530117 33018 33021 33022 33023 33026 33027 33029 33030 33032 33036 33040 33043 33044 500241 500244 500245 500246 500247 500248 500253 500254 500256 500257 500258 500259 500260 500261 500262 500263 500264 500265 500266 500267 500268 500269 500270 500271 500272 500273 500274 500275 500276 500277 500278 500279 500283 500284 500285 500286 500287 500288 500293 500296 500298 500299 500300 500302 500303 500304 500305 500306 500307 500308 500309 500310 500311 500312 500313 500314 500315 500316 500317 500318 500319 500320 500321 500322 500323 500324 500325 500326 500327 500328 500329 500330 500331 500332 500333 500334 500335 500336 500337 500338 500339 500340 500341 500342 500343 500344 500345 500346 500347 500348 500349 500350 500351 500352 500353 500354 500355 500356 500357 500358 500359 500360 500361 500362 500363 500364 500365 500366 500367 500368 500369 500370 500371 500372 500373 500374 500375 500376 500377 500378 500379 500380 500381 500382 500383 500384 500385 500386 500387 500388 500389 500390 500391 500392 500393 500394 500395 500396 500397 500398 500399 500400 500401 500402 500403 500404 500405 500406 500407 500408 500409 500410 500411 500412 500413 500414 500415 500416 500417 500418 500419 500420 500421 500422 500423 500424 500425 500426 500427 500428 500429 500430 500431 500432 500433 500434 500435 500436 500437 500438 500439 500440 500441 500442 500443 500444 500445 500446 500447 500448 500449 500450 500451 500455 500456 500457 500458 500459 500460 500461 500462 500463 500464 500465 500466 500467 500468 500469 500470 500471 500472 500473 500474 500475 500476 500477 500478 500479 500480 500481 500482 500483 500484 500485 500486 500487 500488 500489 500490…
FDA’s list runs to 4,560 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.
Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Macedonia Mexico Moldova Netherlands Nigeria Pakistan Panama Philippines Poland Romania Russian Federation Saint Lucia Saint Pierre and Miquelon Saudi Arabia Serbia Slovakia Spain Sweden Taiwan Thailand Tunisia Turkey Turkmenistan United Kingdom Uzbekistan Viet Nam
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 Apr 25, 2023.
- FDA classified it on Jul 28, 2023.
- FDA’s Enforcement Report published it on Aug 9, 2023.
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 4,560 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.