Azurion recallZ-1647-2023 · Philips Medical Systems Nederland B.V. · initiated Mar 21, 2023

Why it was recalled

Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure

FDA root cause category: Under Investigation by firm

What the company is doing

Philips issued Urgent Medical Device Letter to US consignees via e-mail on March 21, 2023 and certified email on March 29, 2023. Letters outside of the U.S.A. will be distributed through the local Philips Organizations. Letter states reason for recall, health risk and action to take: Keep this Medical Device Correction with the documentation of the system until Philips corrects your system. Circulate this notice to all users of the system so that they are aware of the issue. Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Medical Device Correction. US: Please return this signed form via email to: [email protected] or alternatively via regular mail to Philips at 222 Jacobs Street, Cambridge, MA 02141 for the attention of Mr. Roland Telson / 3rd Floor Philips is working on a software release that will correct this issue (reference FCO72200528). In the interim, until this software is available and installed in your affected system(s), Philips will be removing the Log Trace Files from the affected systems to free up disk capacity (reference FCO72200529). Philips will be prioritizing these activities based on the time the affected software release has been installed in the Philips Azurion system. You will be contacted by your local Philips representative to schedule these activities. If you need any further information or support concerning this issue, contact your local Philips representative.

Recall details

Recall number

Z-1647-2023

Status

Open, Classified

Initiated by the company

Mar 21, 2023

Posted by the FDA

Sep 30, 2024

Recalling firm

Philips Medical Systems Nederland B.V.

Quantity

USA: 1063 R.O.W. 2136

Product code

OWB

FDA submissions

K181830

Distribution

Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Dominican Rep Ecuador Egypt Estonia Finland France French Polynesia Germany Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Latvia Lebanon Lithuania Macao Macedonia Malaysia Mexico Morocco Myanmar Nepal Netherlands New Zealand Nicaragua Nigeria Norway Oman Pakistan Palestine Palestine, State of Panama Peru Philippines Poland Portugal Puerto Rico Qatar Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan Ukraine United Kingdom Utd.Arab.Emir. Uzbekistan Vietnam Yemen

Product description

Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion 7M12: 722078, 722223; (8) Azurion 7M20 : 722079, 722224

Devices named in this recall

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

• Azurion Azurion 7 M20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  32 recalls2 deaths2,308 reports
• Azurion Azurion 7 M20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  28 recalls1 death2,176 reports
• Azurion Azurion 7 M12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls2 deaths1,087 reports
• Azurion Azurion 7 M12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls2 deaths835 reports
• Azurion Azurion 7 B20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls1 death634 reports
• Azurion Azurion 7 B20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls594 reports
• Azurion Azurion 5 M20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls201 reports
• Azurion Azurion 7 B12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  23 recalls232 reports
• Azurion Azurion 7 B12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  21 recalls222 reports
• Azurion Azurion 5 M12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  21 recalls1 death197 reports
• Azurion Azurion 3 M15

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  20 recalls2 deaths205 reports
• Azurion Azurion 3 M15

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  21 recalls104 reports
• Azurion Azurion 3 M12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  20 recalls121 reports
• Azurion Azurion 3 M12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  20 recalls73 reports

Product lines

• AzurionPhilips Medical Systems Nederland B.V. · 22 models · 9,199 reports · 71 recalls