Canon Solid State X-ray Imager Recall Due to Loose Screws
Canon is recalling 468 Solid State X-ray Imagers because screws holding the 55REF circuit board are loosening and roaming inside the sealed sensor.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Canon Inc. is recalling 468 units of the Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G, and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. The affected units have catalog numbers 3930B002AA, 3928B002AA, and 4066B002AA.
The recall is being conducted because screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor. This defect poses a risk of harm to patients or operators, although specific injury reports are not detailed in the source text.
The affected devices were distributed nationwide in the USA. Consumers and healthcare facilities should stop using these devices and contact Canon Inc. for instructions on repair or replacement.
The recalled product
- Product
- Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
- Manufacturer
- Canon Inc.
- Affected units
- 468
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog numbers 3930B002AA
- 3928B002AA
- and 4066B002AA.
Distribution
Distributed nationwide across the United States.
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