Recall Z-1271-2021 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Canon Medical System, USA, INC.
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
| Date | Dec 8, 2020 |
| Status | Open, Classified |
| Reason | System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. |
| Root cause | Component design/selection |
| Action | On 01/12/2021, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter via USPS return receipt mail to customers informing them that the catheterization tables may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. Additionally, the manual operation of the tabletop longitudinal or lateral movement will become heavy or hard to move due to the loosening of the bolts. Customers are instructed/informed: a. Should the table top tilt during a procedure before the bolts are replaced and secured, to ensure the safety of the p |
| Quantity | Total of all Systems = 145 systems (U.S.) |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, WA, WI and WV. The countries of Canada, China, Japan, Korea, and Singapore. |
| 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 |