Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Reported: June 17, 2020 Initiated: March 3, 2020 #Z-2325-2020
Product Description
Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Reason for Recall
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Details
- Recalling Firm
- Canon Medical System, USA, INC.
- Units Affected
- 46
- Distribution
- US Nationwide distribution including in the states of PA, AR, OH, NC, CA, IA, GA, IL, AL, WV, LA, MO, FL, MS, TX, AZ, MA, NJ, MD, NY, NV, OK, WI, PR.
- Location
- Tustin, CA
Frequently Asked Questions
What product was recalled? ▼
Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.. Recalled by Canon Medical System, USA, INC.. Units affected: 46.
Why was this product recalled? ▼
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2020. Severity: Moderate. Recall number: Z-2325-2020.
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