Recall Z-2284-2023 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20. X-ray Image guided Therapy System.
| Date | Aug 2, 2023 (initiated Jun 12, 2023) |
| Status | Open, Classified |
| Reason | The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage. |
| Root cause | Component design/selection |
| Action | Customers were mailed a recall notification dated 6/8/23 notifying them of this medical device correction. Customers are asked to retain the correction notice until all on-site are corrected, ensuring they are available to those who operate the device. If cracks in the FlexMove Carriage and/or abnormal noise during transversal movements of the C-Arc are observed, customers are to contact Philips so their field inspection may be prioritized. A diagram of crack locations on the FlexMove Carriage was provided for user reference. Customers are asked to return the provided Response Form no later th |
| Quantity | 648 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Kenya, South Korea, Libya, Lithuania, Malaysi |
| 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 |