System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M

FDA device recall Z-3165-2024 · posted 2024-09-18 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reason for recall

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.

Action taken

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

Root cause

Device Design

Status

Open, Classified

Product code

OWB

Quantity affected

7091 units

Distribution

Nationwide, Canada and Worldwide: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Brazil Brunei Darussalam Bulgaria Cam

Date initiated

2024-08-22

Date posted

2024-09-18

Location

Best, Netherlands

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