Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO
FDA device recall Z-1616-2010 · posted 2010-05-19 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- Hitachi determined that the mounting method for a Compensation Coil did not include an appropriate factor of safety, so it is possible that the coil could fall, contacting the patient table and potentially putting a patient at risk.
- Action taken
- On 4/15/2010 the firm sent Device Correction Notice letters to their customers identifying the affected product and informing them of the potential problem. The letter stated that the firm will change the coil mounting method used at the customer's facility, if necessary, at no cost to the customer. A service rep will contact them to schedule a visit to correct the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- MOS
- Quantity affected
- 56 devices
- Distribution
- Nationwide Distribution -- AL, AR, AZ, CA, CT, DC, DE, FL, ID, IL, IN, KY, LA, MD, MO, NJ, NY, OH, OK, OR, RI, TN, TX, VA & WA.
- Date initiated
- 2010-04-19
- Date posted
- 2010-05-19
- Date terminated
- 2012-09-21
- 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 AIRIS II (K001334) | Hitachi Medical Systems America, Inc. | 2000-07-06 |