FDA Device recall Z-2327-2020
Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used…
- FDA Device
- Class II
- ongoing
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used… by Canon Medical System Usa, citing bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2327-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-03-03 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Canon Medical System Usa |
| Distribution | US |
Product
Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - 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
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Identifiers
| code_info | Serial Numbers: AGB1692005, AGB17Z2010, AGA1552003, AGB17Y2009, AGB1682004, AGA1492002, AGC1822012, A5C1922001,…Serial Numbers: AGB1692005, AGB17Z2010, AGA1552003, AGB17Y2009, AGB1682004, AGA1492002, AGC1822012, A5C1922001, AGB1712007, AGC1952014, AGB1482001, AGC1822011, BGB1992001, AGC18X2013, AGB16Z2006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2327-2020%22
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