AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
FDA device recall Z-1104-06 · posted 2006-06-10 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 5
- Distribution
- The devices were distributed to five (5) customers located in four (4)states: Colorado, Ohio, Nebraska and Texas
- Date initiated
- 2006-04-28
- Date posted
- 2006-06-10
- Date terminated
- 2008-11-24
- 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 |
|---|---|---|
| HITACHI ALTAIRE (K002420) | Hitachi Medical Systems America, Inc. | 2000-10-17 |
| AIRIS II (K974212) | Hitachi Medical Systems America, Inc. | 1998-02-09 |