Azurion recallZ-3165-2024 · Philips Medical Systems Nederland B.V. · initiated Aug 22, 2024

Why it was recalled

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

FDA root cause category: Device Design

What the company is doing

Philips Issued URGENT Medical Device Correction Letter (Philips Reference # 2023-IGT-BST-006) on 8/22/24. Letter states reason for recall, health risk and action to take: a. Affected systems may continue to be used in accordance with their Instructions for Use (IFU) and the instructions below. b. Avoid that operators or bystanders stand underneath the Cable Hose Carriers, especially when moving or turning the system monitor. c. Avoid having the patient located underneath the Cable Hose Carriers (e.g., during transport). d. If you notice loose or broken bolts and/or broken plastic parts of the Cable Hose Carriers (see Figure 2), please contact your local Philips representative immediately. e. As part of the preventive maintenance cycle, Philips will check the Monitor Ceiling Suspension, including the Cable Hose Carriers, as indicated in the Preventive Maintenance Manual Update attached in Appendix B. o Keep a copy of this Preventative Maintenance Manual Update with your current manual. o If you do not use Philips to perform the preventative maintenance on your system, provide a copy of the Preventive Maintenance Manual Update to your qualified and authorized service provider. f. Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue and follow the instructions above. Keep this Medical Device Correction letter with the documentation of the system until Philips corrects your system. g. Complete and return the attached response form (page 4) to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction letter and understanding of the issue and required actions to be taken. Philips is redesigning the Cable Hose Carriers. Once the redesigned cable hose carriers are available, Philips will contact you to schedule a visit to install them in the affected system(s) (reference FCO72200536, FCO72200576, and FCO72200577). As of the date of t

Recall details

Recall number

Z-3165-2024

Status

Open, Classified

Initiated by the company

Aug 22, 2024

Posted by the FDA

Sep 18, 2024

Recalling firm

Philips Medical Systems Nederland B.V.

Quantity

7091 units

Product code

OWB

FDA submissions

K200917

Distribution

Nationwide, Canada and Worldwide: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Brazil Brunei Darussalam Bulgaria Cambodia Cayman Islands Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cuba Curacao Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Estonia Ethiopia Fiji Finland France French Polynesia Georgia Germany Ghana Gibraltar Greece Guadeloupe Guinea Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Israel Italy Jamaica Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Kyrgyzstan Lao People's Democratic Republic Latvia Lebanon Libya Lithuania Macao Macedonia Malaysia Maldives Malta Martinique Mauritania Mauritius Mexico Mongolia Morocco Myanmar Nepal Netherlands New Caledonia New Zealand Nicaragua Norway Oman Pakistan Palestine, State of Panama Papua New Guinea Paraguay Peru Philippines Poland Portugal Qatar R¿union Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sudan Sweden Switzerland Syrian Arab Republic Taiwan Tanzania Thailand Trinidad and Tobago Tunisia Turkey Turkmenistan Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Venezuela Viet Nam Virgin Islands (U.S.) Yemen

Product description

System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion 7 B20 722225 Azurion 7 B12 722224 Azurion 7 M20 722223 Azurion 7 M12 722222 Azurion 3 M15 722221 Azurion 3 M12 722079 Azurion 7 M20 722078 Azurion 7 M12 722068 Azurion 7 B20 722067 Azurion 7 B12 722064 Azurion 3 M15 722063 Azurion 3 M12

Devices named in this recall

18 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
• Azurion Azurion 7 M20

  Philips Medical Systems Nederland B.V. · Interventional fluoroscopic x-ray system
  11 recalls1 death108 reports
• Azurion Azurion 7 B12

  Philips Medical Systems Nederland B.V. · Interventional fluoroscopic x-ray system
  11 recalls5 reports
• Azurion Azurion 7 B20

  Philips Medical Systems Nederland B.V. · Interventional fluoroscopic x-ray system
  10 recalls1 death50 reports
• Azurion Azurion 7 M12

  Philips Medical Systems Nederland B.V. · Interventional fluoroscopic x-ray system
  10 recalls27 reports

Product lines

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

Other products in the same recall event

The FDA groups related products into one recall event (event 95256).

• Z-3166-2024 · Open, Classified
  System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 Allura Xper FD20 OR Table 722029 A…