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Class 2 Device Recall Panorama 1.0T |
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Date Initiated by Firm |
April 30, 2007 |
Date Posted |
June 27, 2007 |
Recall Status1 |
Terminated 3 on September 21, 2011 |
Recall Number |
Z-0984-2007 |
Recall Event ID |
37950 |
510(K)Number |
K041602
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Product Classification |
magnetic resonance imaging system - Product Code LNH
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Product |
Panorama 1.0T MRI |
Code Information |
Site #s: 521810, 533745, 533860, 533900, 534276, 534278, 535230, 535273, 535664, 536972, 537852, 538574, 538616, 539265, 539374, 539514, 540482, 541065, 541851, 542236, 542244, 543822, 544039, 544148, 544696, 544723, 545034, 545143, 545732, 545902, 545918, 545981, 546206, 546594, 546654, 546722, 546728, 547843, 547897, 548040, 548041, 548064, 549389, 549909, 550324, 550358, 550398, 550439, 550449, 550621, 551025, 551583, 552453, 552526, 552609 and 47480028. |
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 425-487-7665
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Manufacturer Reason for Recall |
Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.
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FDA Determined Cause 2 |
Other |
Action |
On 4/30/07 Philips sent an Urgent Device Correction letter dated April 25, 2007 via certified mail to customers. The letter advises customers of the issue and that that a representative will visit the sites, inspect and correct the problem if indicated. |
Quantity in Commerce |
56 units |
Distribution |
Units were distributed throughout the US to 1,078 hospitals and medical centers. |
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 = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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