# K002420: Hitachi Altaire

- Pathway: 510(k) (Abbreviated)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Oct 17, 2000 after 70 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K050602: Altaire (2005), 17 descendants of its own
- K052172: HHF1 Magnetic Resonance Imaging System (2005), 16 descendants of its own
- K083533: Echelon C Mri System (2009), 11 descendants of its own
- K113145: Echelon Oval Mri System (2012), 10 descendants of its own
- K151015: ECHELON Oval V 5.0 MRI System (2015), 6 descendants of its own

## Recalls of this device
- Feb 11, 2008 · Not classified · Z-1542-2008: The firm's Altaire MR Scanner's Emergency Rundown Switch Unit (ERDU), that is used to shut down the device in an emergency, was found to be defective. An ERDU failure could delay or prevent patient ac
- Jul 30, 2007 · Not classified · Z-1263-2007: Overheating; A portion (balun assembly) of the cable that connects the shoulder coil to the actual MRI unit may malfunction and result in overheating of the balun assembly. The overheating of the balu
- Apr 28, 2006 · Not classified · Z-1104-06: 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.
- Feb 21, 2006 · Not classified · Z-0910-06: The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.
- Jan 27, 2006 · Not classified · Z-1103-06: Circuit Failure-There is the potential risk of the Phase Loss Detector Safety Device (PHSEN PCB) malfunctioning in the event of a power loss. The circuit may fail to turn off the system main breaker w
- Jun 30, 2005 · Not classified · Z-0888-05: Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
- Apr 11, 2005 · Not classified · Z-0797-05: The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.
- Nov 18, 2004 · Not classified · Z-0846-05: The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the comp

Source page: https://510kreport.com/device/K002420
Methodology: https://510kreport.com/methodology