Recall Z-1726-2020— Canon Medical System, USA, INC.

Name: FDA recall Z-1726-2020
Creator: U.S. Food and Drug Administration
Published: 2019-03-25

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2019-03-25. It names one FDA 510(k) clearance: K170177. Product: Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1. Reason: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2019-03-25
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K170177 — Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1Toshibamedical Systems Corporation·cleared 2017-06-30

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

Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1

Reason for recall

Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.

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