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.
- Company
- Canon Medical System, Usa, Inc.
- Recall Initiated
- December 8, 2020
- Recall Number
- Z-1271-2021
- Quantity
- Total of all Systems = 145 systems (U.S.)
- Firm Location
- Tustin, CA
Reason for Recall
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
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.
Lot / Code Info
Table CAT-880B Models: INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/BHUP INFX-8000F/AH INFX-8000F/AH INFX-8000F/UU INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/BH Table Serial Numbers: 99E1582258 99F18Y2428 99C1482200 99E15Y2271 99F1862406 99G19Z2438 99E1662308 99E1762365 99A1337005 99F1852401 99E1612286 99E1712347 99E1712345 99C14Z2224 99E1592262 99G1972436 System Serial Numbers: AHA1582003 AHC18Y2013 AHA1482001 AHA15Y2005 AHC1862012 BHB19Z2002 AHB1662007 AHB1762010 UUB12X2034 AHC1852011 AHA1612006 AHB1712009 AHB1712008 AHA14Z2002 AHA1592004 BHB1972001
Root Cause
Component design/selection
Action Taken
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 patient, please move the table top to the position of the patients foot and refrain from operating the tabletop as much as possible. Please contact your service representative. b. Share this information with all users and reviewing radiologist as well as clinical engineering, and the biomedical group at their facility. c. Complete and return the attached Response Form and fax it to the toll free number 877-349-3054, or return via email to RAffairs@us.medical.canon For any questions or assistance, contact Regulatory Affairs Manager at 800-421-1968 or the local service representative at 800-521-1968.