RegWardenFDA facility compliance records
Facility

CANON INC.

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2010: 1 recalls; 2012: 1 recalls1’10’111’12’13’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (2)

Devices registered here (3)

  • System, Imaging, Pulsed Echo, Ultrasonic
    Product code IYO (opens in a new tab) · Class II · Radiology · 21 CFR 892.1560
  • Transducer, Ultrasonic, Diagnostic
    Product code ITX (opens in a new tab) · Class II · Radiology · 21 CFR 892.1570
  • System, Imaging, Pulsed Doppler, Ultrasonic
    Product code IYN (opens in a new tab) · Class II · Radiology · 21 CFR 892.1550

Recalls & enforcement

  • Class IITerminated2012-12-05
    Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability.
  • Class IITerminated2010-11-01
    Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CANON INC. (FEI 3012761544) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012761544-canon-inc/

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