MAUDE Adverse Event Report: PHILIPS HEALTHCARE (SUZHOU) CO., LTD. INCISIVE CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	INCISIVE CT
Medical Device Problem Codes	Mechanical Problem (1384); No Fail-Safe Mechanism (2990)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint has been evaluated based on the information provided; it was reported that the longitudinal toothed bar(fail-safe device) was noted to be incorrectly installed upon arrival.There is no allegation of death or serious injury.However, it is uncertain whether this event is likely to recur and cause a serious injury during service.Therefore, based on the available information, this issue has been initially determined to be a reportable event.
Additional Manufacturer Narrative
Note: we have not completed our investigation of this event.Upon completion, we will submit a follow-up emdr report.Internal cross reference: complaint pr# (b)(4).
Additional Manufacturer Narrative
Philips received a complaint regarding an incisive ct system, indicating that the longitudinal toothed bar was incorrectly installed upon delivery.The issue was identified by the field service engineer (fse) during system installation and was immediately corrected on-site, with no death or serious injury reported.Per design, the patient table is equipped with front and rear brakes to prevent any unexpected movement when powered off, and the service manual provides detailed instructions for failsafe use and status inspections; even in a worst-case scenario, the fse would be positioned beside ,not under the patient table.A technical investigation has been completed, revealing that the supplier had incorrectly installed the failsafe installation rail, which can be fitted in either direction and lacks a poka-yoke mechanism or other orientation safeguard; furthermore, the supplier's work instruction (wi) does not specify instructions or verification steps for correct orientation.Based on the supplier's extended investigation, it has been confirmed that no other install bases (ib) are affected.The supplier has implemented a requirement to verify the assembly orientation of the failsafe installation rail and introduced a checklist for orientation verification during final inspection, effective march 2026.The investigation concludes that all necessary corrective and preventive actions have been initiated.

• Brand Name: INCISIVE CT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS HEALTHCARE (SUZHOU) CO., LTD.; no. 258, zhongyaun road; suzhou industrial park; suzhou jiangsu 21502 4; CH 215024
• Manufacturer (Section G): PHILIPS HEALTHCARE (SUZHOU) CO., LTD.; no. 258, zhongyaun road; suzhou industrial park; suzhou jiangsu 21502 4; CH 215024
• Manufacturer Contact: estelle hilas ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 24696044
• Report Number: 3009529630-2026-100020
• Device Sequence Number: 21343672
• Product Code: JAK
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K212441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: INCISIVE CT
• Device Catalogue Number: 728144
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 07/14/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/23/2026; 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown