Recall Z-2327-2020 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Canon Medical System, USA, INC.
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.
| Date | Mar 3, 2020 |
| Status | Open, Classified |
| Reason | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. |
| Root cause | Process control |
| Action | On 03/03/20, Urgent Medical Device Correction notices were mailed to Radiology Managers/Directors. To correct this issue, the bolts holding the longitudinal movement of the table will need to be inspected to determine if the bolts are tightened to specification. Recalling firm service representatives will contact customers to set up appointments to inspect bolts. Radiology Managers/Directors were advised of the following: a) Should this problem occur before your appointment with the recalling firm's service representative, please stop using the system and contact the service representative. b |
| Quantity | 15 |
| Distribution | US Nationwide distribution including in the states of PA, AR, OH, NC, CA, IA, GA, IL, AL, WV, LA, MO, FL, MS, TX, AZ, MA, NJ, MD, NY, NV, OK, WI, PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081624 | INFX-8000F (INFINIX CSI AND INFINIX DPI) Toshiba America Medical Systems, In.C, Jun 23, 2008 |