Recall Z-1289-2022— Canon Medical System, USA, INC.

Name: FDA recall Z-1289-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-03

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2022-05-03. It names one FDA 510(k) clearance: K181804. Product: System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW. Reason: CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2022-05-03
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K181804 — Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation·cleared 2018-08-02

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

System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW

Reason for recall

CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.

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