Z-0532-2021Class II

CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model...

Name: Z-0532-2021 CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model...
Creator: Canon Medical System, USA, INC.
Published: 2020-10-08
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2020-10-08 / Terminated / root cause: design

FDA source

Canon Medical System, USA, INC. began a recall of CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H -... on 2020-10-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0532-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-08
Posted: 2020-12-03
Terminated: 2022-12-06
Recalling firm: Canon Medical Systems USA, Inc.
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 configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 10/08/2020, Canon Medical Systems sent a "Urgent: Medical Device Correction" Notification to all affected consignees via Fax. In addition to informing consignees about the correction, Canon as consignees to take the following actions: 1. On a daily basis, prior to the installation of the new cable with the modified routing, please perform the start-up inspection described in the Operation Manual to confirm that the FPD up and down movement operates normally. Additionally, please have available a mobile device which can perform fluoroscopy such as a surgical C-arm device or another catheter inspection/IVR room. 2. If the above event occurs, please stop using the device and contact your Canon service representative. . 3. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility. 4. Please complete and return the attached form and fax it to the toll free number at the top of the form. This form may also be sent via email to [email protected]. 5. Thank you for your prompt attention to this matter. If you have any questions, please feel free to contact Terry Schultz Regulatory Affairs Manager at (800) 421-1968 or your local Canon service representative at (800) 521-1968.
Quantity in commerce: 14 units
Distribution: US Nationwide distribution including in the states of LA, CA, CO, WV, GA, NH, FL, PA, WI, MN, ID.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0532-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0532-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-03

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)