Z-0532-2021 Class II Terminated
FDA device recall Z-0532-2021 was initiated by Canon Medical System, USA, INC. on October 8, 2020 and is designated Class II. 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 … The recall status is terminated (terminated December 6, 2022). Affected quantity: 14 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2020
- Initiation Date
- October 8, 2020
- Termination Date
- December 6, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
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.
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.
Distribution Pattern
US Nationwide distribution including in the states of LA, CA, CO, WV, GA, NH, FL, PA, WI, MN, ID.
Code Information
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