FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
- Recall number
- Z-0029-2007
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
- Status
- Terminated
- Initiated
- 2006-08-16
- Posted
- 2006-10-12
- Terminated
- 2012-04-13
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 348 units
- Distribution
- Nationwide and Puerto Rico.
- Lot, serial or model codes
- AIRIS - Serial Number Range: A001, AG001-AG039, A901; MRP-7000 - Serial Number Range: 7001- 7154.
- 510(k) numbers
- ["K911667","K945155"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 1528028
- Firm city
- Twinsburg
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28