CLASS II ONGOING Device recall · Reported 29 May 2024 · FDA Enforcement Report

Incisive CT - Computed Tomography X-Ray System intended to recalled

Philips North America is recalling Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images, distributed nationwide in the US. The recall was initiated on 15 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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

Quantity recalled155 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1872-2024
FDA event ID: 94536
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 15 Apr 2024
FDA classified: 20 May 2024
Reported: 29 May 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Imaging Equipment

Timeline

15 Apr 2024	Recall initiated by company
20 May 2024	Classified by FDA	+35 days
29 May 2024	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Is Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images recalled?

Yes. Philips North America recalled Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images on 15 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-1872-2024.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide - US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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