The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures.
Recall
- Recall Number
- Z-1188-2016
- Event Number
- 73348
- Firm
- Richard Wolf Medical Instruments Corp.
- FEI Number
- 1418479
- Product Code
- FWE
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- February 29, 2016
- Terminated
- July 3, 2019
- Address
- 353 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3110
Description
The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures.
Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting.
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 and others which we want to prevent with this measure. The firm is asking all end users to take the following step: Discontinue use of the affected devices until the conversion kits have been installed by a qualified service technician. Make sure that all users of affected medical devices are informed in their organization of the urgent safety information. If the end user has passed on products to third parties they should pass on a copy of this information and inform the recall contact person at Richard Wolf. Please make sure that the information is observed at their organization until all necessary internal measures have been completed. The end user should provide confirmation of receipt of this urgent safety information and answer the enclosed questionaire form which the firm asks to send to Richard Wolf at the following e-mail, [email protected] by February 22, 2016. The firm asking that recipients to acknowledge receipt of the safety information in order to avoid receiving more reminders from Richard Wolf. The firm will send new monitor holding plate(s}, (643301264 conversion kit for monitor holding plate) once the form is received. The firm asks that qualified service technician install the new monitor holding plate (643301264 Conversion kit for monitor holding plate) in accordance with the enclosed assembly instructions and discard
Nationwide Distribution including Virginia, Pennsylvania, Florida, California, Texas, North Carolina and Illinois.
108 units