Altaire, Magnetic Resonance Imaging Device.
FDA device recall Z-0846-05 · posted 2005-05-17 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- 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 compressor.
- Action taken
- The firm implemented site inspections of customers beginning on 11/19/04 which have been completed. Customers that had the suspect component had it replaced.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 189 devices
- Distribution
- Direct accounts located in AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
- Date initiated
- 2004-11-18
- Date posted
- 2005-05-17
- Date terminated
- 2008-01-04
- 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 |