| Class 2 Device Recall Philips BV Endura | |
Date Initiated by Firm | October 04, 2011 |
Date Posted | October 27, 2011 |
Recall Status1 |
Terminated 3 on January 12, 2017 |
Recall Number | Z-0117-2012 |
Recall Event ID |
60064 |
510(K)Number | K010435 |
Product Classification |
System, x-ray, fluoroscopic, image-intensified - Product Code JAA
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Product | Philips BV Endura Fluoroscopic Image Intensified X-ray
Catalog Number: 718074
Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system. |
Code Information |
Shipped from June~2010 to 26 Jul 2011 S/N: 1413 1438 1492 1504 1567 1567 1620 1633 1634 1691 1765 1800 |
Recalling Firm/ Manufacturer |
Philips Healthcare Inc. 3000 Minuteman Road Andover MA 01810
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For Additional Information Contact | SAME 978-687-1501 |
Manufacturer Reason for Recall | Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Philips Healthcare Inc., sent an "URGENT - Field Safety Notice" dated September 30, 2011 to all affected customers. The notice identifies the following: what the problem is and under what circumstances it can occur; the actions that should be taken by the customer/user in order to prevent risks for patients or users and the actions planned by Philips Medical Systems to correct the problem. The notice contains important information for the continued safe and proper use of the equipment and customers were advised to retain a copy with the equipment Instruction for Use. The notice stated that Philips will replace the front plates for systems on the Unit Affected List by the end of June 2012. The notice instructed customers to contact Philips Healthcare representative for further information or support. |
Quantity in Commerce | 12 units in the US |
Distribution | Worldwide Distribution - USA (nationwide) and the countries of: Australia, Austria, Belgium, Bharain, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Netherlands, Norway, Portugal, Russian Fed., Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, and United Kingdom. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JAA
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