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Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
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HIGH
Canon Medical System Recalls Digital Radiography Device Over Software Issue
Canon Medical System recalled eight digital radiography systems on September 2, 2025. The software issue may leave X-ray areas partially covered by static images. Users should stop using the device immediately and follow recall instructions.
Quick Facts at a Glance
- Recall Date
- September 2, 2025
- Hazard Level
- HIGH
- Brand
- Canon Medical System, USA
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL
Hazard Information
It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Canon Medical System, USA, INC. or your healthcare provider for instructions
Product Details
The recall involves eight models of Canon's digital radiography/fluoroscopy system. The affected serial numbers include SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, and SZA2442004. These devices were distributed in the U.S.
The Hazard
The SPOT Fluoro software may revert the collimator blades to a larger default ROI, partially obscuring the intended X-ray area. This issue arises during the acquisition program change, potentially leading to diagnostic errors.
Reported Incidents
Currently, no injuries or incidents have been reported in connection with this recall. However, the software defect poses a significant risk during use.
What to Do
Stop using the device immediately. Follow the recall instructions provided by Canon Medical System. Contact your healthcare provider for further guidance.
Contact Information
For more information, contact Canon Medical System, USA, at their official website or the recall page.
Key Facts
- Recall date: September 2, 2025
- Report date: October 15, 2025
- High hazard level due to software issue
- Eight units recalled
- No incidents reported yet
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Safety Assessment
Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeDigital Radiography/Fluoroscopy System
Sold At
Unknown
Product Details
Categories
Model Numbers
SZA2422001
SXA2432001
SUC23Z2014
BBF2392003
SUC2392013
+3 more
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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