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Class 2 Device Recall Allura Xper FD20/10 |
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Date Initiated by Firm |
September 24, 2007 |
Date Posted |
December 07, 2007 |
Recall Status1 |
Terminated 3 on May 03, 2012 |
Recall Number |
Z-0330-2008 |
Recall Event ID |
44959 |
510(K)Number |
K033737
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Product Classification |
Angiographic x-ray system - Product Code IZI
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Product |
Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021 |
Code Information |
Serial numbers affected: 18, 19, 22, 23, 24, 32, 33, 34, 36, 38, 52, 54, 56, 67, 68, 69, 71, 73, 74, 82, 84, 94, 99, 100, 102, 103, 106, 108, 112, 113, 116, 124, 125, 126, 131, 133, 141, 142, 148, 154, 157, 173, 174, 176, 178, 187, 191, 192, 197, 199, 212, and 691. |
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 |
Sarah Baxter 425-487-7602
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Manufacturer Reason for Recall |
Inaccurate anatomical measurements when using the optional SmartMask feature
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FDA Determined Cause 2 |
Device Design |
Action |
The recalling firm sent customers an Urgent Device Correction notification letter dated 09/21/07 via certified mail - return receipt requested. This notification provided a short term work around for the device defect. For a permanent fix, the recalling firm is developing software update to check for mismatch at the start of a subtracted fluoroscopy run, and will contact customers to schedule an install. Installation is expected to begin 10/2007 and be completed 06/2008. |
Quantity in Commerce |
53 units |
Distribution |
Nationwide |
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 and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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