Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Philips Medical Systems Nederland B.V. Allura Xper R8.1 System with Poly-G Stand [HKMD No.: 100206].
According to the MHRA, Philips has identified an issue in a limited number of Lifetime Extension (LTE) Kits, for Allura R8.1 systems with a lifetime exceeding 10 years from their installation, where a wrong bolt was included. A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
In systems utilizing a Poly-G Stand, the full-threaded bolt is intended to fix the propeller motor of the C-arm to the Poly-G Stand. The propeller motor cannot be properly secured with a half-threaded bolt. This improper fixation may lead to an uncontrolled C-arm movement, which can result in unavailability of Cone Beam CT imaging.
For further information, please visit: https://mhra-gov.filecamp.com/s/d/HTIPqBkquGwYIG0P
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Aug 2024