| Class 2 Device Recall Philips Medical Systems Allura Xper FD20C | |
Date Initiated by Firm | July 08, 2014 |
Date Posted | November 07, 2014 |
Recall Status1 |
Terminated 3 on January 18, 2017 |
Recall Number | Z-0182-2015 |
Recall Event ID |
68723 |
510(K)Number | K033737 |
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product | Philips Medical Systems Allura Xper FD20C with software version R8.2.O
System Code: 722035.
The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. |
Code Information |
Allura Xper Software version R8.2.0 |
Recalling Firm/ Manufacturer |
Philips Medical Systems, Inc. 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact | 978-687-1501 |
Manufacturer Reason for Recall | Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system. |
FDA Determined Cause 2 | Software design |
Action | Philips Medical Systems issued certified letters on 7/8/14 and receipt returned for tracking purposes. A mandatory Field Change Order with reference FC072200253 is being released that requires Philips field service engineers to install Software release R8.2.0.3. If you need any further information or support concerning this issue, contact your local Philips representative: SUPPORT 1-800-722-9377. |
Quantity in Commerce | 2 units |
Distribution | Distributed in the states of IL, and TN, and the countries of Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, and Viet Nam. |
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 = OWB
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