| Class 2 Device Recall Easy Diagnost Eleva | |
Date Initiated by Firm | October 30, 2013 |
Date Posted | December 02, 2013 |
Recall Status1 |
Terminated 3 on January 09, 2017 |
Recall Number | Z-0431-2014 |
Recall Event ID |
66705 |
510(K)Number | K031535 |
Product Classification |
System, x-ray, stationary - Product Code KPR
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Product | Easy Diagnost Eleva
Universal Fluoroscopic applications |
Code Information |
706050, 706083, 706088 |
Recalling Firm/ Manufacturer |
Philips Medical Systems, Inc. 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact | 800-722-9377 |
Manufacturer Reason for Recall | The delivered application software was an outdated version to the model of equipment. |
FDA Determined Cause 2 | Software design |
Action | Philips Medical Systems sent an Urgent - Field Safety Notice dated October 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusromers were informed that the delivered application software was an outdated version to the model of their expipment and that a Philips Field Engineer will be implementing an upgrade of the application software. Customers were instructed to review the information contained in the letter with all memebers of their staff who need to be aware of its contents. Customers with questions were instructed to contact their Philips representataive: Technical Support Line 1-800-722-9377.
For questions regarding this recall call 1-800-722-9377. |
Quantity in Commerce | 19 devices |
Distribution | Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC. |
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 = KPR
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