Class 2 Device Recall Philips

• Date Initiated by Firm: April 12, 2023
• Date Posted: May 23, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1625-2023
• Recall Event ID: 92238
• 510(K)Number: K180015 K212441
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
• Code Information: UDI-DI: (01)00884838103474(21) Serial Number: 530537 554032 554060 554065 554078
• Recalling Firm/ Manufacturer: PHILIPS HEADQUARTERS CAMBRIDGE; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Philips Customer Care Solutions Center; 800-722-9377
• Manufacturer 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
• FDA Determined Cause: Software design
• Action: 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).
• Quantity in Commerce: 5 units
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JAK