MAUDE Adverse Event Report: PHILIPS INDIA LTD. ZENITION; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	ZENITION 70
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system's wireless footswitch was defective.No harm was reported to philips.We are conservatively reporting this event as the investigation is ongoing.
Additional Manufacturer Narrative
Philips has investigated this complaint.It was identified that the wireless footswitch (wfs) was defective.A quotation was sent to the customer for repair; however the quotation has expired, and no service has been provided by philips.The customer confirmed that they did not want a new wfs and continued using the wired foot switch.To date, no further information has been received.The zenition 70 has been designed to have a built-in redundancy in the form of a hand switch.If the wireless footswitch fails to activate x-rays, then the user can switch to the wired or the hand switch seamlessly to continue and complete the procedure.At the time this complaint was received, philips did not have enough information to exclude the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, new information has been received which has led to the determination that this scenario is not likely to cause or contribute to death or serious injury if it were to recur.As per the system's instructions for use (ifu), before using the system, it should be checked that the wireless foot switch functions with the system and alternatively, a wired foot switch and hand switch is also available for use.This has led to the determination that this scenario is not likely to cause or contribute to death or serious injury if it were to recur.Based on the investigation results, philips concludes that the complaint is not reportable.The codes were updated based on the investigation outcome.

• Brand Name: ZENITION
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS INDIA LTD.; plot no. b-79, midc,; phase-ii, chakan; pune 41050 1; IN 410501
• Manufacturer (Section G): PHILIPS INDIA LTD.; plot no. b-79, midc,; phase-ii, chakan; pune 41050 1; IN 410501
• Manufacturer Contact: marjan vos ; plot no. b-79, midc,; phase-ii, chakan; pune 41050-1 ; IN 410501
• MDR Report Key: 21252225
• Report Number: 3003768277-2025-000787
• Device Sequence Number: 20847065
• Product Code: OWB
• UDI-Device Identifier: 00884838091528
• UDI-Public: (01)00884838091528
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K183040
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: Health Professional
• Device Model Number: ZENITION 70
• Device Catalogue Number: 718133
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2019
• 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