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

FDA device recall Z-1625-2023 · posted 2023-05-23 · Open, Classified

Recall details

Recalling firm

PHILIPS HEADQUARTERS CAMBRIDGE

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

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).

Root cause

Software design

Status

Open, Classified

Product code

JAK

Quantity affected

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 Portu

Date initiated

2023-04-12

Date posted

2023-05-23

Location

Cambridge, MA

Related 510(k) clearances