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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, Optima MR450w 1.5T MR systems

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 Class 2 Recall
GE Healthcare, Optima MR450w 1.5T MR systems
see related information
Date Posted February 18, 2011
Recall Status1 Terminated on February 04, 2012
Recall Number Z-1377-2011
Recall Event ID 57270
Premarket Notification
510(K) Number
K091536 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product GE Healthcare, Optima MR450w 1.5T MR systems The GE Signa® MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa® MR750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including, but not limited to, head, neck, TMVJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Signa® MR750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa® MR750 System are similar to those for the Signa® HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System.
Code Information 00000000HG0010 00000000HG0015 00000000HG0016 00000000HG0017 00000000HG0019 00000000HG0020 00000000HG0022 00000000HG0023 00000000HG0024 00000000HG0025 00000000HG0028 00000000HG0030 00000000HG0034 00000000HG0038 00000000HG0039 00000000515M27 00000000610M26 00000000650M22 00000000678M23 00000000679M21 00000000703M29 00000000731M20 00000000763M23 00000000764M21 00000000776M25 00000000778M21 00000000813M26 00000000814M24 00000000840M29 00000000862M23 00000000889M26 00000000911M28 00000000927M24 00000000933M22 00000000990M22 00000000994M24 00000001009M20 00000001012M24 00000001057M29 00000001059M25 00000001060M23 00000000931M26 00000000929M20 00000000991M20 00000000AANW81 00000000HG0031 00000000HG0006 00000000HG0027 00000000922M25 00000000HG0009 00000000HG0026 00000000HG0029 00000000HG0035 00000000HG0040 00000000611M24 00000000762M25 00000000809M24 00000000811M20 00000000923M23 00000000934M20 00000000992M28 00000001006M26 00000000993M26 00000000HG0032 00000000810M22 00000000863M21 00000000877M21 00000000928M22
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
GE Healthcare has become aware that during certain service procedures, there is a potential for electric shock associated with the gradient cooling manifold hoses of your MR750, MR450, and MR450w MR systems that may impact service or maintenance personnel's safety. The gradient cooling manifolds used on the affected systems may contain electrically conductive hoses, which become live when the gra
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 16, 2011, to all affected customers. The letter was addressed to Hospital Administrator / Risk Manger, Radiology Department Manager and Maintenance / Biomedical Engineering Department. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction and Contact Information. Customers were instructed to follow appropriate lockout/tagout (LOTO) procedures. Customers were instructed to contact GE Healthcare engineering at 843-687-7213 or 843-697-3009 for instructions on how to proceed. For questions concerning the notiifcaton customers were instructed to contact their local Support Engineer.
Quantity in Commerce 68
Distribution Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, LA, MD, MA, MI, MO, NV, NJ, NY, NC, OR, PA, SC, TN, TX, WA, WI. and the countries of AUSTRALIA, BRAZIL, CANADA, EHYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, ITALY, JAPAN, KUWAIT, QATAR, REPUBLIC OF KOREA, SWITZERLAND, TAIWAN, and the UNITED KINGDOM.UNITED KINGDOM, TAIWAN, SWITZERLAND, REPUBLIC OF KOREA, QATAR, KUWAIT, JAPAN, ITALY, INDIA, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, CANADA, BRAZIL, AUSTRALIA.
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 = GE MEDICAL SYSTEMS, LLC
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