Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device an
FDA device recall Z-2366-2015 · posted 2015-08-10 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.
- Action taken
- Hitachi sent an Urgent: Device Removal Notice letter date April 24, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers to discontinue using the Coil Extension Cable and that a Field Service Engineer will schedule a visit to remove the cable. For questions call 800-800-3106 ext 3720.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MOS
- Quantity affected
- 173 units
- Distribution
- US Nationwide in the states: AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI & WY and the
- Date initiated
- 2014-04-25
- Date posted
- 2015-08-10
- Date terminated
- 2018-08-24
- 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 |
|---|---|---|
| MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K072279) | Hitachi Medical Systems America, Inc. | 2007-09-21 |