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U.S. Department of Health and Human Services

Class 2 Device Recall ACHIEVA 3.0T and Panorama 1T

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 Class 2 Recall
ACHIEVA 3.0T and Panorama 1T
see related information
Date Posted December 21, 2010
Recall Status1 Terminated on December 28, 2010
Recall Number Z-0794-2011
Recall Event ID 57351
Premarket Notification
510(K) Numbers
K031815  K041602 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit. Consists of diagnostic devices that produce cross sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body.
Code Information Site numbers: 505048, 505705, and 41445594.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
For Additional Information Contact Philips Healthcare Call Center
800-722-9377
Manufacturer Reason
for Recall
The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action On 05/12/2009, Philips began sending out the URGENT-Field Safety Notice MR Accessory Cart to their consignees. The letter identified the affected product and stated that the drawer rails were made from magnetic material and were not according specification. The hazards involved were also provided along with how to identify the affected product. The firm issued the FCO 78100296 and the firm's Field Service Engineer replaced the magnetic rails with the non-magnetic rails at the consignee's site. The consignees can contact contact the Philips Healthcare Call Center at 800-722-9377 #5 (then follow prompts) and reference FCO 78100296 with any communication.
Quantity in Commerce 3 units
Distribution Nationwide Distribution -- IL, MI, and MD.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS
510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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