Recall Z-2315-2012— Toshiba American Medical Systems Inc

Name: FDA recall Z-2315-2012
Creator: U.S. Food and Drug Administration
Published: 2012-02-21

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2012-02-21, terminated 2012-09-07. It names one FDA 510(k) clearance: K060003. Product: Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.. Reason: The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2012-02-21
Terminated: 2012-09-07
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K060003 — EXCELART VANTAGE ZGVToshibamedical Systems Corporation·cleared 2006-01-18

K-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

Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.

Reason for recall

The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil.

Data sourced from openFDA. This site is unofficial and independent of the FDA.