Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
System Model: Ultimax-i Recalled by Canon Medical System, USA, INC. Due to During a procedure, when images were acquired, and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Canon Medical System, USA, INC. directly.
Affected Products
System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Quantity: 11 units
Why Was This Recalled?
During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired.
Where Was This Sold?
This product was distributed to 10 states: CA, CT, ID, LA, MT, NV, OH, SC, WV, WI
About Canon Medical System, USA, INC.
Canon Medical System, USA, INC. has 49 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report