| Class 2 Device Recall Echelon and Oasis | |
Date Initiated by Firm | June 15, 2012 |
Date Posted | August 23, 2012 |
Recall Status1 |
Terminated 3 on February 19, 2013 |
Recall Number | Z-2254-2012 |
Recall Event ID |
62870 |
510(K)Number | K052172 K072279 |
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
Product | Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices.
Product Usage:
The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination. |
Code Information |
Echelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951 |
Recalling Firm/ Manufacturer |
Hitachi Medical Systems America Inc 1959 Summit Commerce Park Twinsburg OH 44087
|
For Additional Information Contact | Douglas J. Thistlethwaite 330-425-1313 Ext. 3720 |
Manufacturer Reason for Recall | Hitachi discovered a software error with a feature called Multi-Planar Reconstruction
(MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new image set from another view (i.e. axial to coronal, coronal to sagittal, etc.). The error causes the first image in the dataset to have a right/left reversed orientation. The software error can occur randomly when execu |
FDA Determined Cause 2 | Software design |
Action | Hitachi sent a Device Correction Notice letter dated June 18, 2012 to all affected customers. All letters are recorded by tracking number and date received by the consignee. The letter identified the affect product, problem and actions to be taken. All sites will be visited by Hitachi Service to install the software update to permanently resolve the issue at no cost to the facility. Software correction is targeted to start by September 1, 2012. For question contact the Manager of Regulatory Affairs at 800-800-3106 x3720 |
Quantity in Commerce | 165 units |
Distribution | US Nationwide Distribution - including the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and Mexico. |
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 = LNH
|
|
|
|