Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whol
FDA device recall Z-2037-2012 · posted 2012-07-19 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstructions are queued for processing, if a queue is suspended and the task order changed, the second queue may not reconstruct the full range of slices. This may result in missing diagnostic data.
- Action taken
- Hitachi sent a "Device Correction Notice" dated May 4, 2012 to their customers. The notice identified the affected product, problem and actions to be taken. Customers were instructed to "not use the Reconstruction Status" function to suspend active reconstructions until the software problem can be corrected. They also informed their customers that a representative will visit their facility to install the software update to permanently resolve the issue at no cost to the facility. For further information regarding this notice call 800-800-3106 x3720.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- Six (6) units
- Distribution
- US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.
- Date initiated
- 2012-05-04
- Date posted
- 2012-07-19
- Date terminated
- 2013-02-19
- 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 |
|---|---|---|
| SCENARIA WHOLE-BODY X-RAY CT SYSTEM (K101888) | Hitachi Medical Systems America, Inc. | 2011-04-08 |