PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C

Recall number

Z-3167-2024

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C

Status

Open, Classified

Initiated

2024-08-22

Posted

2024-09-18

Terminated

not on file

Reason

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.

Root cause

Device Design

Action

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

Quantity

250 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 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

Lot, serial or model codes

Model Product UDI-DI: N/A 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C All serial numbers

510(k) numbers

["K002016"]

PMA numbers

not on file

Product code

OWB

Firm FEI

3002807880

Firm city

Best

Firm state

not on file

Firm country

Netherlands

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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