MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
This recall has been terminated (originally issued October 12, 2006).
- Recall Initiated
- August 16, 2006
- Posted
- October 12, 2006
- Terminated
- April 13, 2012
- Recall Number
- Z-0029-2007
- Quantity
- 348 units
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate.
Distribution
Nationwide and Puerto Rico.
Lot / Code Info
AIRIS - Serial Number Range: A001, AG001-AG039, A901; MRP-7000 - Serial Number Range: 7001- 7154.
Root Cause
Other
Action Taken
On 8/16/2006, Hitachi issued two (2) Device Correction letters. The first letter was addressed to the five (5) customers whose system units are currently ''de-installed''. This letter informs the customers of the problem and asks that the customer(s) please contact the firm''s Customer Service Center on their toll-free tel. # 1-800-800-4925, in order to schedule a device correction should the customer ever re-activate/install their system(s). The second letter, issued to the customers with activated MRP-7000 and/or AIRIS MRI systems, informs the customers of the problem, and states that a HMSA Service (person) will be contacting the customer in order to schedule a device correction which should address the problem.