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U.S. Department of Health and Human Services

Class 2 Device Recall Intera 1.5T and 1.5T Achieva MRI systems

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  Class 2 Device Recall Intera 1.5T and 1.5T Achieva MRI systems see related information
Date Initiated by Firm September 30, 2008
Date Posted September 22, 2010
Recall Status1 Terminated 3 on September 30, 2010
Recall Number Z-2461-2010
Recall Event ID 49594
510(K)Number K052013  
Product Classification Coil, magnetic resonance, specialty - Product Code MOS
Product Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x.
Code Information Devices are identified as Site numbers: 544006, 537871, 534961, 544704, 545154, 545236, 545219, 545943, 546637, 545879, 545914, 543286, 547585, 548729, 550876, 553379, 550044, 554797, 41443789, 555412, 41444993, 41445232, 556803, 557348, 557344, 557513, 557179, 557644, 557560, 551656, 558845, 41446147, 552550, 552516, 555787, 41445636, 41455922, 83325, 558369, 86968, 101408, 101877, 102110, 102353, 102004, 104343, and 41455948.
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Philips Call Center
800-722-9377
Manufacturer Reason
for Recall		 The cables of the coil may become too hot and cause burns when placed too close to the patient. While using the 1.5T Sense XL Torso coil, unwanted radiofrequencies (RF) interaction with the patient can occur. Especially in combination with high SAR levels and when the RF cables of the coil are too close to the patient, this RF interaction has resulted in RF burns to patients.
FDA Determined
Cause 2		 Other
Action Philips Healthcare issued URGENT-Device Correction Notices dated September 30, 2008 to their consignees. The notice identified the recalled device as 1.5 Intera and 1.5T Achieva MRI systems, described the risk to patients, and the actions to be taken by customers.. The firm has issued Field Change Order (FCO) 78100242. Field service representatives will visit each consignee and conduct a hardware upgrade, applying a sleeve over the cable that will ensure proper spacing between the cable and patient, reducing the chance of RF interaction and burns. The consignees should contact the Philips Call Center at 1-800-772-9377, #5 #3, #1 and reference "FCO 78100242 - PATIENT CABLE SLEEVE FOR 1.5T SENSE XL TORSO COIL".
Quantity in Commerce 47 units total (Achieva 1.5T and Intera 1.5T)
Distribution Nationwide Distribution: Throughout USA. No distribution to foreign consignees.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MOS and Original Applicant = PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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