Date Initiated by Firm | July 09, 2008 |
Date Posted | August 10, 2010 |
Recall Status1 |
Terminated 3 on October 27, 2010 |
Recall Number | Z-2194-2010 |
Recall Event ID |
48998 |
510(K)Number | K031535 K063781 |
Product Classification |
Stationary X-ray or Solid X-ray Imager - Product Code KPR
|
Product | The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system. |
Code Information |
Serial Numbers 353320, 362600, 362601, 364209, 364210, 375245 and 375850. |
Recalling Firm/ Manufacturer |
Philips Medical Systems North America Co. Phillips 22100 Bothell Everett Hwy Bothell WA 98021-8431
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For Additional Information Contact | 425-487-7602 |
Manufacturer Reason for Recall | Potential for bright artifacts to appear on the patient image from a previous exposure. |
FDA Determined Cause 2 | Other |
Action | On July 9, 2008, Philip Medical System began sending out the URGENT-Device Correction letter to their consignees. This letter describes the recalled product as EasyDiagnost Eleva with DRF system with SW release 1.0.
The firm informs the consignees that under special circumstances there is a small possibility that bright artifacts appear on a patient image from a previous exposure.
The consignees are advised to take care about the X-ray field limitation. If the detector is not affected by direct radiation, no problem will occur. If direct radiation reaches the detector, the collimation should not be too tight, such that the area of direct radiation is larger than 1.2 inch x 1.2 inch (or 30 mm x 30 mm). The minimum area is needed to detect and prevent memory artifacts.
The firm will upgrade any affected products with the Field Change Order (FCO)70600031 and it will be implemented before the end of December 2008. The upgrade software is 1.0.3. The correction would be free of charge and the consignees should contact Philips Call Center at 800-772-9377, #5, #2. |
Quantity in Commerce | 7 |
Distribution | Product was distributed in AZ, CA, FL and WA. |
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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