Recall Z-2282-2012— Toshiba American Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2009-07-13, terminated 2012-09-04. It names one FDA 510(k) clearance: K072606. Product: Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.. Reason: 1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco.
- Recalling firm
- Toshiba American Medical Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2009-07-13
- Terminated
- 2012-09-04
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
Reason for recall
1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco
Data sourced from openFDA. This site is unofficial and independent of the FDA.