Azurion 5 with a Certeray generator-To perform image… recallZ-1177-2024 · Philips Medical Systems Nederland B.V. · initiated Feb 6, 2024

Why it was recalled

Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

FDA root cause category: Under Investigation by firm

What the company is doing

Philips notified U.S customers by Urgent Medical Device Correction letter on 06-Feb-2024 via certified mailing via United States Postal Service. " Letters outside of the U.S.A. will be distributed through the Philips Markets Organizations. Letter states reason for recall, health risk, and action to take: Circulate this Letter to all clinical staff and any service personnel that may service the system so that they are aware of the issue. " Keep this Urgent Medical Device Correction Letter with the documentation of the system until Philips implements the correction in your system. " If the Certeray generator fails, please stop using the system and contact the Customer Care Solutions Center. " Place a copy of this Letter in a visible place in the Control and Technical rooms (e.g., posted on the door). " Please complete and return the attached response form (on page 3) to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction and understanding of the issue and required actions to be taken. 5. Actions planned by Philips IGTS to correct the problem As a remedy, Philips will replace the Power Inverter in the Azurion generator cabinet in all affected Azurion systems through the implementation of Field Change Order (FCO72200544). If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).

Recall details

Recall number

Z-1177-2024

Status

Open, Classified

Initiated by the company

Feb 6, 2024

Posted by the FDA

Feb 22, 2024

Recalling firm

Philips Medical Systems Nederland B.V.

Quantity

27 units

Product code

OWB

FDA submissions

K200917

Distribution

Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Macao, Macedonia, Malaysia, Morocco, Netherlands, Norway, Oman, Palestine, State of Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom.

Product description

Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

• Azurion Azurion 5 M20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls201 reports
• Azurion Azurion 5 M12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  21 recalls1 death197 reports
• Dynamic Coronary Roadmap Dynamic Coronary Roadmap - 2

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  4 recalls0 reports

Product lines

• AzurionPhilips Medical Systems Nederland B.V. · 22 models · 9,199 reports · 71 recalls
• Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V. · 3 models · 10 reports · 9 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 93966).

• Z-1176-2024 · Open, Classified
  Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
• Z-1178-2024 · Open, Classified
  Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 72222…