FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: MRP-7000, AIRIS Magnetic Resonance Imaging Systems
- Recall number
- Z-1105-06
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- MRP-7000, AIRIS Magnetic Resonance Imaging Systems
- Status
- Terminated
- Initiated
- 2006-03-17
- Posted
- 2006-06-10
- Terminated
- 2008-11-13
- Reason
- Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a possible patient mis-diagnosis.
- Root cause
- Other
- Action
- On 3/17/2006, the firm began conducting a survey of all afftected customer sites in order to determine if corrected software has been installed on the unit(s) at each customer location. If the corrected software has not been installed, the firm''s Field Service Engineers will install software upgrades as necessary.
- Quantity
- 283
- Distribution
- Nationwide-The devices were distributed to consignees located througout the United States.
- Lot, serial or model codes
- Asset Tag Numbers: 7001-7154; A007-A901; AG004-AG039
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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