Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
- Company
- Philips Headquarters Cambridge
- Recall Initiated
- April 12, 2023
- Posted
- May 23, 2023
- Recall Number
- Z-1623-2023
- Quantity
- 22 units
- Firm Location
- Cambridge, MA
Reason for Recall
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
Distribution
AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam
Lot / Code Info
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
Root Cause
Software design
Action Taken
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).