FDAFDA · Food and drugs·Recall number Z-0532-2021
CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - 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.
Published December 9, 2020 · Recall initiated: October 8, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in a delay with procedure and/or potential damage to the patients blood vessels due to removal without visibility.
What to do
Voluntary: Firm initiated · FAX
Recall details
- Manufacturer
- Canon Medical System, USA, INC.
- Distributor
- US Nationwide distribution including in the states of LA, CA, CO, WV, GA, NH, FL, PA, WI, MN, ID.
- Lot
- Affected Serial Numbers: 1 AFA1662001, 2 AFB1872005, 3 AFB1832003, 4 AFB1872004, 5 AFB1892006, 6 BFA18Y7001, 7 AEA17X2001, 8 AFA1692002, 9 AEB1812002, 10 BFA1932001, 11 BFB1952003, 12 BFB1942002, 13 BFB1972004, 14 BFB1972005, 15 AFB1892007, 16 BEC2032001, 17 BFC2062007, 18 BFC2062008, 19 BHA1992001, 20 BFC2012006
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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