Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Number

FDA device recall Z-2953-2024 · posted 2024-09-04 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reason for recall

The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel.

Action taken

An URGENT Medical Device Correction notification letter dated 8/6/24 was sent to customers. Actions that should be taken by the customer/user in order to prevent risks for patients a. Affected systems may continue to be used in accordance with their Instructions for Use (IFU) and the instructions below. b. If you experience inconsistent (not smooth) or no motorized longitudinal movement of the FlexArm stand and you receive (or have received) the error messages described in Section 1 of this Medical Device Correction letter, please report the issue to Philips. c. If the FlexArm s longitudinal motorized movement stops during a procedure, position the C-arm manually by using the handgrips and brake controls on both sides of the FlexArm stand or reposition the table in longitudinal position if the available distance is sufficient. d. As part of the preventative maintenance cycle Philips will clean the rails, friction wheel and bearings as indicated in the Preventive Maintenance Update attached in Appendix A. 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. e. Circulate this Urgent Medical Device Correction Letter to all users so that they are aware of the issue and follow the instructions above. Keep this Urgent Medical Device Correction with the documentation of the system until Philips corrects your system. f. Complete and return the attached response (page 05) form 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 actions required. Actions planned by Philips Image Guided Therapy Systems to correct the problem Philips will replace the existing longitudinal bearings on the affected Azurion 7M20 systems with FlexArm sta

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OWB

Quantity affected

927 systems

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2024-08-06

Date posted

2024-09-04

Location

Best, Netherlands

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