Recall Z-2953-2024 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
| Date | Sep 4, 2024 (initiated Aug 6, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 927 systems |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200917 | Azurion R2.1 Philips Medical Systems Nederland B.V., May 1, 2020 |