Agency classClass IIOur severity:High FDA (Devices)·Z-0532-2021·Announced 2020-12-09

Canon Flat Panel Monitor Recall Due to Cable Breakage Risk

Canon Medical System is recalling 14 CAS-930A Flat Panel Monitors because the cable may break during procedures, potentially causing delays or vessel damage.

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 medical device with a risk of harm (potential damage to blood vessels) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Canon Medical System, USA, INC. is recalling 14 units of the CAS-930A Flat Panel Monitor (FPD). These monitors are used in conjunction with the Canon Interventional Angiography System, specifically the Infinix-8000C and Infinix-8000H models. The devices are digital radiography/fluoroscopy systems indicated for diagnostic and angiographic procedures on blood vessels in the heart, brain, abdomen, and lower extremities.

The recall is due to a potential defect where the cable of the Flat Panel Detector may break during a procedure. If this occurs, the x-ray device may stop before the examination is completed. This malfunction could result in a delay to the procedure and/or potential damage to the patient's blood vessels if the device is removed without visibility.

The affected units were distributed nationwide in the United States, including in Louisiana, California, Colorado, West Virginia, Georgia, New Hampshire, Florida, Pennsylvania, Wisconsin, Minnesota, and Idaho. The recall covers 20 specific serial numbers, including AFA1662001, AFB1872005, and BFC2062008. Healthcare facilities should contact Canon Medical System to arrange for the necessary corrective actions.

The recalled product

Product: 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…
Manufacturer: Canon Medical System, USA, INC.
Category: Medical Device — Imaging Equipment
Hazard: equipment-failure
injury-risk
Affected units: 14

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 (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Same manufacturer · Canon Medical System, USA, INC.

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