Canon USA Inc – FDA Warning Letter, Jul 23, 2012

The FDA issued a Warning Letter to Canon USA, Inc. on January 7, 2013, following an inspection from June 12 to July 23, 2012, at their Irvine, California facility. The inspection found that Canon's Digital Radiography Sensor Panel devices (CXDI-55G, CXDI-50C, CXDI-70C) were misbranded due to violations of Medical Device Reporting (MDR) and Reports of Corrections and Removals regulations.

Key violations include: 1. **Failure to report device malfunctions:** Canon failed to report device malfunctions that would likely cause or contribute to death or serious injury within 30 days, as required by 21 CFR 803.50(a)(2). Examples cited include multiple MDR numbers related to device malfunctions leading to a recall. While Canon's responses regarding corrective actions for timely reporting appeared adequate, the initial failure was noted. 2. **Inadequate MDR procedures:** Canon's written MDR procedures (SOP M-1006, Rev. J) failed to establish internal systems for timely identification, communication, and evaluation of events (21 CFR 803.17(a)). Specifically, definitions of "reasonably known" and "reasonably suggests" were omitted, and "becomes aware" and "malfunction" definitions were inconsistent with 21 CFR 803.