| Class 2 Device Recall Hitachi Oasis Magnetic Resonance Scanners Software | |
Date Initiated by Firm | September 01, 2009 |
Date Posted | May 04, 2010 |
Recall Status1 |
Terminated 3 on February 24, 2012 |
Recall Number | Z-1534-2010 |
Recall Event ID |
54264 |
510(K)Number | K072279 |
Product Classification |
system, nuclear magnetic resonance imaging - Product Code IWE
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Product | Hitachi Oasis Magnetic Resonance Scanners Software V1.0C
The intended use: The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. |
Code Information |
Model #'s: M001 - M043 |
Recalling Firm/ Manufacturer |
Hitachi Medical Systems America Inc 1959 Summit Commerce Park Twinsburg OH 44087
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For Additional Information Contact | 330-425-1313 Ext. 3720 |
Manufacturer Reason for Recall | The device has a software error that could potentially lead to a misdiagnosis. |
FDA Determined Cause 2 | Software design (manufacturing process) |
Action | Sites have already been corrected. Software updated from V1.0C to V2.0B |
Quantity in Commerce | 43 |
Distribution | Nationwide distribution: AZ, CA, CT, DE, FL, GA, IA, IL, IN, LA, MD, MI, MO, NC, NY, OH, OK, OR, PA, RI, SC, TX, VA, WA, WI, and WY. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = IWE
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