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 Healthcare (Suzhou) Co., Ltd. DigitalDiagnost C50 1.1 [REF: 712204] & DigitalDiagnost C50 1.0 [REF: 712201] [HKMD No.: 200458].
According to the MHRA, the manufacturer has identified an issue that may occur with the DigitalDiagnost C50 system if Planned Maintenance (PM) is not completed as prescribed in the Instructions for Use (IFU). If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result, there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, which may result in injuries to patients and users
For further information, please visit https://mhra-gov.filecamp.com/s/d/sPzMOkcy7neXv7Zv
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 Mar 2023