PHILIPS HEADQUARTERS CAMBRIDGE Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
Brand
PHILIPS HEADQUARTERS CAMBRIDGE
Lot Codes / Batch Numbers
UDI-Di: (01)00884838105508(21) Serial Numbers: 34053, 34092, 34164, 34168, 34179, 34195
Products Sold
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
PHILIPS HEADQUARTERS CAMBRIDGE is recalling Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144 due to Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Philips issued Urgent Medical Device Correction Letters on 4/12/23 US consignees via Certified United States Postal Service (USPS) with delivery confirmation. International global markets were notified of the issue and instructed to distribute the FSN to affected consignees in accordance with local requirements. Letter states reason for recall, health risk and action to take: Refer to the IFU of your Incisive CT system to ensure proper use of the Precise Position function (IFU Section 4.9). " If the patient orientation automatically selected by Precise Position (see Figure 2) is inconsistent with the preset protocol, please correct the settings as described below: o Manually select the correct orientation in the Select Patient Orientation area in the New Patient interface, or o Open the Select Patient Orientation list by clicking the patient orientation icon in the left upper corner of the series list and select the correct orientation. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. " Place this URGENT Medical Device Correction Letter with your system documentation. " Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. 5. Actions planned by Philips to correct the problem Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site and install a software upgrade to address the issue (reference FCO72800793). Additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CA, OK, TX
Page updated: Jan 10, 2026