MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
FDA device recall Z-0029-2007 · posted 2006-10-12 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 348 units
- Distribution
- Nationwide and Puerto Rico.
- Date initiated
- 2006-08-16
- Date posted
- 2006-10-12
- Date terminated
- 2012-04-13
- Location
- Twinsburg, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AIRIS (K945155) | Hitachi Medical Systems America, Inc. | 1995-05-24 |
| HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE (K911667) | Hitachi Medical Systems America, Inc. | 1991-05-30 |