Date Initiated by Firm | February 06, 2006 |
Date Posted | February 28, 2006 |
Recall Status1 |
Terminated 3 on May 20, 2008 |
Recall Number | Z-0582-06 |
Recall Event ID |
34602 |
510(K)Number | K033737 |
Product Classification |
System, X-Ray, Angiographic - Product Code IZI
|
Product | Allura Xper FD10 x-ray system |
Code Information |
site numbers provided with the Allura Xper FD10/10 |
Recalling Firm/ Manufacturer |
Philips Medical Systems North America Co. Phillips 22100 Bothell Everett Hwy Bothell WA 98021-8431
|
For Additional Information Contact | Sarah Baxter 425-487-7665 |
Manufacturer Reason for Recall | Potential lock-up of system requiring reboot of system. |
FDA Determined Cause 2 | Other |
Action | On 2/6/06 the firm sent a Product Safety Notification letter to the customers that have devices installed. The letter advises of the problem, and to restart the device if it locks up. The letter also states that the firm will be performing upgrades of the devices. |
Quantity in Commerce | 55 devices total (Allura Xper FD10/10 & Allura Xper FD10) |
Distribution | Nationwide. Devices were distributed to 42 hospitals/medical centers (35 customers have devices set up) throughout the USA. |
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 = IZI
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