Toshiba Aquilion ONE CT SystemTSX-301 A/2D
FDA device recall Z-2339-2010 · posted 2010-09-01 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB.
- Action taken
- Toshiba America Medical System Inc (TAMS) sent an Urgent: Medical Device Correction dated January 14, 2009 to their consignees. The letter described the issue and provided instructions to test the device to determine if it is an affected device. If the device is affected, contact the Toshiba service representative at 800 521-1968. Consignees were requested to complete and fax a response form to Toshiba.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 16
- Distribution
- Nationwide Distribution: including the states of AL, CA, FL, GA, KY, MA, MD, MT, NV, NY, OH, PA, and Puerto Rico.
- Date initiated
- 2009-02-03
- Date posted
- 2010-09-01
- Date terminated
- 2011-09-02
- Location
- Tustin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM (K072606) | Toshiba America Medical Systems, In.C | 2007-10-02 |