CLASS II Device recall · Reported 9 Dec 2020 · FDA Enforcement Report
CAS-930A Flat Panel Monitor (FPD) used in conjunction recalled
Canon Medical System, USA is recalling CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional, distributed nationwide in the US. The recall was initiated on 8 Oct 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0532-2021
- FDA event ID
- 86650
- Recalling firm
- Canon Medical System, USA, Tustin, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Oct 2020
- FDA classified
- 3 Dec 2020
- Reported
- 9 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- FAX
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 8 Oct 2020 | Recall initiated by company | |
| 3 Dec 2020 | Classified by FDA | +56 days |
| 9 Dec 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution including in the states of LA, CA, CO, WV, GA, NH, FL, PA, WI, MN, ID.
Nationwide CaliforniaColoradoFloridaGeorgiaIdahoLouisianaMinnesotaNew HampshirePennsylvaniaWisconsinWest Virginia
Questions about this recall
Is CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional recalled?
Yes. Canon Medical System, USA recalled CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional on 8 Oct 2020. The recall is Class II and its status is Terminated. Recall number Z-0532-2021.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution including in the states of LA, CA, CO, WV, GA, NH, FL, PA, WI, MN, ID.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Canon Medical System, USA
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|---|---|---|---|---|---|
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Alphenix Infx-8000C, interventional fluoroscopic x-ray system recalled | Canon Medical System, USA | Device Malfunction | Nationwide |
| Device | CLASS II | Alphenix Infx-8000V, interventional fluoroscopic x-ray system recalled | Canon Medical System, USA | Device Malfunction | Nationwide |
| Device | CLASS II | Alphenix Infx-8000H, interventional fluoroscopic x-ray system recalled | Canon Medical System, USA | Device Malfunction | Nationwide |
| Device | CLASS II | Alphenix Infx-8000F, interventional fluoroscopic x-ray system recalled | Canon Medical System, USA | Device Malfunction | Nationwide |
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