FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
- Recall number
- Z-1104-06
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
- Status
- Terminated
- Initiated
- 2006-04-28
- Posted
- 2006-06-10
- Terminated
- 2008-11-24
- Reason
- Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis.
- Root cause
- Other
- Action
- The firm''s Field Service personnel will apprise the customers of this situation during scheduled visits at each customer location. During this visit, the corrected software will be installed by the Hitachi Field Service Technician. The installation of the software upgrades by the service technicians began on 4/28/2006. The firm anticipates that the correction of all units in their inventory as well as those units installed out-in-the-field will becompleted by 6/15/2006.
- Quantity
- 5
- Distribution
- The devices were distributed to five (5) customers located in four (4)states: Colorado, Ohio, Nebraska and Texas
- Lot, serial or model codes
- Serial Numbers: Altaire - L217, L219, L221, L224 and L225; AIRIS II - C686-C688* [*The AIRIS units remained in Hitachi's inventory and were not distributed].
- 510(k) numbers
- ["K002420","K974212"]
- 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