Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body
Medical device recall Z-1872-2024. Published in FDA’s Enforcement Report on May 29, 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 May 29, 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
- 155 units 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 change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
155 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: Unique Device Identifier Rule: {01)00884838105508(21) + Serial number Serial Numbers-Applied to FCO72800820: 34002 34006 34007 34018 34019 34023 34025 34026 34031 34032 34033 34038 34040 34041 34042 34047 34049 34050 34051 34052…
Every code shown here, 1,113 characters
UDI-DI: Unique Device Identifier Rule: {01)00884838105508(21) + Serial number Serial Numbers-Applied to FCO72800820: 34002 34006 34007 34018 34019 34023 34025 34026 34031 34032 34033 34038 34040 34041 34042 34047 34049 34050 34051 34052 34053 34054 34055 34056 34057 34058 34059 34060 34064 34066 34067 34068 34071 34072 34073 34074 34075 34077 34078 34079 34080 34081 34082 34083 34085 34086 34088 34089 34090 34091 34092 34093 34095 34097 34100 34101 34102 34103 34105 34106 34111 34112 34116 34117 34119 34122 34126 34128 34130 34131 34132 34133 34134 34135 34137 34146 34149 34150 34152 34153 34160 34162 34163 34164 34165 34168 34169 34174 34175 34179 34187 34190 34191 34193 34195 34198 34201 34203 34206 34208 34218 34221 34223 34226 34229 34235 34240 34244 34251 34257 34259 34260 34263 34264 34265 34267 34270 34276 34277 34279 34280 34281 34282 34285 34289 34294 34295 34301 34315 34324 34325 34326 34327 34335 34337 34338 34344 34348 34350 34351 34358 34367 34368 34374 34384 34385 550243 550503 Serial Numbers -Applied to FCO72800820: 34337 34350 34341 550503 34351 34358 34367 34368 34374 34384 34385
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 - US Nationwide distribution.
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 15, 2024.
- FDA classified it on May 20, 2024.
- FDA’s Enforcement Report published it on May 29, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America Llc, 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.”
- 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.