PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to…
Medical device recall Z-1507-2024. Published in FDA’s Enforcement Report on Apr 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 Apr 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, and 1 state named
- 428 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?
Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143
428 units, 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 Numbers: 500092 500202 500264 500265 33002 500217 500046 33001 33003 500064 500102 500110 500111 500145 500168 500178 500211 500216 500222 500242 500252 500255 500282 500032 500073 500138 500034 500038…
Every code shown here, 1,997 characters
UDI-DI: (01)00884838085015(21) Serial Numbers: 500092 500202 500264 500265 33002 500217 500046 33001 33003 500064 500102 500110 500111 500145 500168 500178 500211 500216 500222 500242 500252 500255 500282 500032 500073 500138 500034 500038 500069 500091 500135 500087 500041 500056 500089 500103 500105 500116 500123 500125 500136 500152 500200 500213 500219 500233 500256 500045 500024 500028 500122 500173 500283 500003 500020 500052 500075 500118 500134 500146 500149 500150 500218 500223 500232 500210 500225 500049 500067 500076 500081 500249 500129 500141 500142 500143 500144 500155 500156 500160 500161 500175 500181 500182 500185 500186 500187 500190 500191 500201 500204 500220 500221 500228 500235 500237 500250 500262 500266 500267 500268 500272 500275 500278 500284 500179 500195 500258 500031 500159 500074 500230 500240 500002 500035 500040 500158 500097 500043 500263 500205 500184 500274 500203 500128 500259 500080 500126 500206 500207 500171 500183 500188 500194 500059 500245 500248 500051 500189 500078 500153 500157 500229 500276 500199 500176 500177 500196 500047 500010 500036 500044 500079 500096 500106 500212 500226 500227 500241 500099 500060 500071 500082 500113 500120 500121 500124 500163 500215 500247 500251 500253 500254 500257 500269 500270 500271 500273 500279 500083 500132 500108 500164 500244 500001 500004 500011 500012 500013 500014 500017 500039 500054 500055 500058 500090 500127 500131 500197 500139 500154 500162 500231 500066 500048 500026 500062 500068 500100 500107 500109 500137 500174 500209 500214 500224 500234 500238 500239 500030 500133 500104 500018 500119 500061 500169 500029 500005 500019 500023 500180 500198 500208 500114 500130 500165 500166 500167 500042 500192 530147 530013 530052 530019 530035 530018 530146 530155 530148 530016 530012 530011 530014 530017 530039 530023 530132 530145 530040 530108 530036 530025 530095 530034 530031 530026 530083 530029 530154 530142 530015 530037 530033 530030 530149 530050 530021 530096 530143…
FDA’s list runs to 3,039 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 including Puerto Rico Foreign: Albania Argentina Australia Austria Bangladesh Bolivia Brazil Bulgaria China Czech Republic Denmark Ecuador Egypt France Germany Greece Hungary India Indonesia Iraq Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kuwait Latvia Lebanon Libya Malaysia Myanmar Nepal Netherlands Norway Pakistan Palestine, State of Peru Philippines Poland Puerto Rico Qatar R¿union Romania Russian Federation Saudi Arabia Senegal Serbia Spain Sweden Switzerland Thailand Tunisia Turkey United Arab Emirates United Kingdom Uzbekistan Viet Nam
The states and territories these words name
- Puerto Rico
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 Dec 24, 2020.
- FDA classified it on Apr 9, 2024.
- FDA’s Enforcement Report published it on Apr 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 3,039 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.