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U.S. Department of Health and Human Services

Class 2 Device Recall Panorama 1.0T

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 Class 2 Device Recall Panorama 1.0Tsee related information
Date Initiated by FirmApril 30, 2007
Date PostedJune 27, 2007
Recall Status1 Terminated 3 on September 21, 2011
Recall NumberZ-0984-2007
Recall Event ID 37950
510(K)NumberK041602 
Product Classification magnetic resonance imaging system - Product Code LNH
ProductPanorama 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
For Additional Information ContactSarah Baxter
425-487-7665
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.
FDA Determined
Cause 2		Other
ActionOn 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 Commerce56 units
DistributionUnits were distributed throughout the US to 1,078 hospitals and medical centers.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = LNH
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