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Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the ...

FDA Device Recall #Z-1872-2024 — Class II — April 15, 2024

Recall Summary

Recall Number Z-1872-2024
Classification Class II — Moderate risk
Date Initiated April 15, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips North America Llc
Location Cambridge, MA
Product Type Devices
Quantity 155 units

Product Description

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

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

Distribution Pattern

Worldwide - US Nationwide distribution.

Lot / Code Information

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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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