PHILIPS HEADQUARTERS CAMBRIDGE: Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

Agency Publication Date: May 23, 2023

Affected Products

Product: Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144

UDI-Di: (01)00884838105508(21) Serial Numbers: 34053, 34092, 34164, 34168, 34179, 34195, 34200 (US) OUS: System Serial Number 34010 34020 34061 34070 34107 34108 34127 34142 34147 34157 34158 34161 34166 34176 34177 34178 34180 34194 34202 500453 500499 500501 500504 500506 500508 500511 500518 500529 550004 550023 550025 550034 550041 550052 550065 550069 550077 550079 550084 550086 550093 550103 550107 550114 550115 550119 550121 550128 550130 550140 550141 550150 550162 550164 550169 550174 550176 550181 550187 550188 550191 550194 550195 550203 550212 550234 550241 550248 550249 550251 550256 550266 550270 552038 552040 554023

Product: Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)

UDI-DI: (01)00884838085015(21) Serial Numbers: 75592542 81629039 82435668 84375501 85146962 85469672 86188405 86188817 86820074 87367597 92174932 92622328 92637836 92680372 92823844 92870027 92889235 94581069 95050209 95055576 96094114 96462378 Serial Numbers: 75592542 81629039 82435668 84375501 85146962 85469672 86188405 86188817 86820074 87367597 92174932 92622328 92637836 92680372 92823844 92870027 92889235 94581069 95050209 95055576 96094114 96462378

Product: Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)

UDI-DI: (01)00884838103467 (21) Serial Number: 102342065

Product: Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)

UDI-DI: (01)00884838103474(21) Serial Number: 530537 554032 554060 554065 554078

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92238

Status: Active

Manufacturer: PHILIPS HEADQUARTERS CAMBRIDGE

Manufactured In: United States

Units Affected: 4 products (7 units US and 76 unit OUS; 22 units; 1 unit; 5 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.