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Class 2 Device Recall Azurion R2.1 |
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Date Initiated by Firm |
November 03, 2023 |
Date Posted |
December 15, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0559-2024 |
Recall Event ID |
93416 |
510(K)Number |
K200917
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Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product |
Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20 |
Code Information |
Mdoel/Product Name/UDI-DI:
722078 Azurion 7 M12 (01)00884838085251(21);
722079 Azurion 7 M20 (01)00884838085268(21);
722223 Azurion 7 M12 (01)00884838099241(21);
722224 Azurion 7 M20 (01)00884838099258(21);
722227 Azurion 5 M12 (01)00884838099227(21);
722228 Azurion 5 M20 (01)00884838099234(21).
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Recalling Firm/ Manufacturer |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
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Manufacturer Reason for Recall |
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose
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FDA Determined Cause 2 |
Device Design |
Action |
Philips issued Urgent Medical Device Correction (UMDC) letter US customers in the US on 11/3/23 and a Field Safety Notice (FSN) to customers outside the US. Letter states reason for recall, health risk and action to take:
As a remedy, Philips is replacing the existing covers of all the affected Philips Allura and Philips Azurion
with the monoplane fixed ceiling mounted systems with a redesigned L-arm rotation cover (bolted
instead of spring clips) to make sure it is resistant to external collisions.
Philips will contact all affected customers to arrange for a Field Service Engineer visit to replace the Larm
rotation cover free of charge (reference FCO72200510 for the Philips Allura systems including the
Philips Poly G H5000, FCO72200511 for the Philips Azurion systems).
If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
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Quantity in Commerce |
3821 units |
Distribution |
Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina, Australia,
Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, CANADA, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic,
Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Gabon, Georgia,
Germany, Ghana, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong,
Hungary, Iceland, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Japan, Jordan,
Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Latvia, Latvia, Republic of
Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Martinique, 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, Puerto Rico, 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,
Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan, Venezuela, Vietnam, Yemen. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems Nederland BV
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