The AIRIS II MR System is an imaging device and is intended to provide the physician with physiological and clinical inf
FDA device recall Z-0429-06 · posted 2006-01-24 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.
- Action taken
- The recalling firm sent a recall/field correction letter, dated 12/1/05 to all consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 670 devices.
- Distribution
- The devices were distributed to FL, WA, IL, TX, NC, NY, OH, CO, LA, NJ, CA, AZ, SC, AR, OK, MN, SD, OR, PA, AL, GA, MD, MS, MO, CT, WI, KY, IN, KS, MA, DE, IA, UT, TN, VA, ID, NE, ND, NV, Puerto Rico,
- Date initiated
- 2005-12-01
- Date posted
- 2006-01-24
- Date terminated
- 2008-10-29
- 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 |
|---|---|---|
| AIRIS II (K974212) | Hitachi Medical Systems America, Inc. | 1998-02-09 |