Azurion 7 M20. X-ray Image guided Therapy System.
Reported: August 9, 2023 Initiated: June 12, 2023 #Z-2284-2023
Product Description
Azurion 7 M20. X-ray Image guided Therapy System.
Reason for Recall
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
Details
- Recalling Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Units Affected
- 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, Malaysia, Maldives, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, & Vietnam.
- Location
- Best, N/A
Frequently Asked Questions
What product was recalled? ▼
Azurion 7 M20. X-ray Image guided Therapy System.. Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Units affected: 648 units.
Why was this product recalled? ▼
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2284-2023.
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