Field safety notice FSN-UK-2024-05
VR-5 nurse handset: cable strain relief
- Issued
- Products
- VR-5
- Status
- Closed
- Last updated
Products affected
VR-5 nurse handsets, part number VR5-0350, serial numbers H5-22-0001 to H5-23-1460.
What has happened
The moulded strain relief on some VR-5 nurse handsets can crack after repeated flexing. If the crack is not noticed, the cable can be damaged where it enters the handset, and the handset may stop working. The bed remains usable from the footboard and the side rail controls.
No patient harm has been reported. Eleven handsets have been returned to us with cracked strain reliefs since March 2024.
Action to be taken by the user
- Check the serial number on the back of each VR-5 nurse handset.
- Inspect affected handsets for cracks at the cable entry before each use until they are replaced.
- Your Van Roon engineer will contact you to arrange replacement.
Contact
For questions about this notice, contact the service desk on 0808 157 0614 (Monday to Friday, 08:00 to 17:30) or service@vanroon.uk, quoting FSN-UK-2024-05.
The competent authorities concerned have been told about this notice. This notice has been sent to every hospital on our records with the products affected.
Issued by Van Roon Medical UK Ltd on behalf of Van Roon Medische Techniek B.V., Leiden, on 7 October 2024.