Events

Recall of Intera 1.5T and 1.5T Achieva MRI systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems North America Co. Phillips.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    49594
  • Event Risk Class
    Class 2
  • Event Number
    Z-2461-2010
  • Event Date Posted
    2010-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73890
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Coil, magnetic resonance, specialty - Product Code MOS
  • Reason
    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.
  • 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".

Device

Intera 1.5T and 1.5T Achieva MRI systems
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: Throughout USA. No distribution to foreign consignees.
  • Product Description
    Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA