System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-800

FDA device recall Z-1289-2022 · posted 2022-06-24 · Open, Classified

Recall details

Recalling firm

Canon Medical System, USA, INC.

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.

Action taken

On or about 04/20/2022, Canon Medical Systems USA, Inc sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter informing customer of a potential issue with your ALPHENIX System when used in combination with a CT system where the CT operations may be restricted by an interlock which is a result of an error "H29 M. Net error. The Error message(s) Gantry reached inner limit or Gantry reached out limit may be seen on the CT System at the time of occurence. The CT system may stop operating properly after an attempt to cancel the error message has been initiated. The error may result in the patient needing to be moved to another system for a repeat scan, which could cause a delay in diagnosis or decrease comfort for the patient. Customers are being informed that the Recalling Firm has developed a software update that will be installed by a representative of Canon Medical Systems USA that should correct the issue/situation. Prior to the install of the software update, the Urgent customer letter provides a Error resetting (workaround) as follows: 1. Hold down the Anatomical angle control selection button and the Override button on the tableside console or the satellite console (option) simultaneously for at least 1 second. 2. Repeat a second time. This should resolve the error on the CT system. For questions, contact Gary Becker, Regulatory Affairs Manager at 800-421-1968 or email gmbecker@us.medical.canon or the Canon Service Representative at 800-521-1968

Root cause

Software design

Status

Open, Classified

Product code

OWB

Quantity affected

6 systems

Distribution

U.S.: CA, CO, FL, NY, and WY O.U.S.: None

Date initiated

2022-05-03

Date posted

2022-06-24

Location

Tustin, CA

Related 510(k) clearances