Hitachi Oasis Magnetic Resonance Scanners Software V1.0C The intended use: The MR system produces transverse, coronal, s
FDA device recall Z-1534-2010 · posted 2010-05-04 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- The device has a software error that could potentially lead to a misdiagnosis.
- Action taken
- Sites have already been corrected. Software updated from V1.0C to V2.0B
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- IWE
- Quantity affected
- 43
- Distribution
- Nationwide distribution: AZ, CA, CT, DE, FL, GA, IA, IL, IN, LA, MD, MI, MO, NC, NY, OH, OK, OR, PA, RI, SC, TX, VA, WA, WI, and WY.
- Date initiated
- 2009-09-01
- Date posted
- 2010-05-04
- Date terminated
- 2012-02-24
- 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 |