Recall Z-1188-2016 ยท FWE Camera, Television, Microsurgical, With Audio
Richard Wolf Medical Instruments Corp.
The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures.
| Date | Feb 29, 2016 |
| Status | Terminated |
| Reason | Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting. |
| Root cause | Process control |
| Action | RICHARD WOLF sent an Urgent Safety Information letter dated March 2, 2016, to all affected consignees. The letter described the nature of the recall regarding the monitor holding plate (VESA 75/100 mount) in our Flexion-Port 300, 350 and 400 swivel arm product series. According to the firm insufficient riveting of the rotation elements the rivets may loosen during continuous use (e.g. when adjusting the tilt angle) and in an extremely unlikely event the monitor holding plate (VESA 75/100 mount) may loosen. According to Richard Wolf this can result in a potential danger for the patient, user a |
| Quantity | 108 units |
| Distribution | Nationwide Distribution including Virginia, Pennsylvania, Florida, California, Texas, North Carolina and Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.