Hitachi Altaire Magnetic Resonance Imaging System
FDA device recall Z-1103-06 · posted 2006-06-10 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- 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 when 2 of the 3 power phases are lost.
- Action taken
- The recalling firm sent a Device Correction Letter dated 1/27/06 to all of their customers. The letter informs the customers of the problem in the (PHSEN PCB) and notifies the customers that an HMSA Field Service Technician will be performing a PCB modification to the unit, on-site, during their next scheduled preventative maintenance visit. Should the customer wish to have the modification performed prior to the representative''s scheduled visit, the letter says that they can telephone their local Field Service Rep. and make arrangements to have the modification performed at their convenience.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 213 devices have been distributed and installed.
- Distribution
- Nationwide-The device was distributed to consignees located throughout the United States.
- Date initiated
- 2006-01-27
- Date posted
- 2006-06-10
- Date terminated
- 2008-11-13
- 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 (K022390) | Hitachi Medical Systems America, Inc. | 2002-10-11 |
| HITACHI ALTAIRE (K002420) | Hitachi Medical Systems America, Inc. | 2000-10-17 |