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.
Medical device manufacturer, Philips, has issued a medical device safety alert concerning its Allura and Azurion Systems [Product Description: Poly G - OMCP - VISUB - CCD (H5000), Allura Xper FD10C, Allura Xper FD10, Allura Xper FD20, Allura Xper FD10, Allura Xper FD20, Allura Xper FD20 OR Table, Integris H5000 C/ Allura 9C, Integris Allura 9, Allura Xper FD10 OR Table, Allura Xper FD20 OR Table, Allura Xper FD10, Allura Xper FD20, Allura Xper FD10 OR Table, Allura Xper FD20 OR Table, Integris Allura 15 & 12 (monoplane), Azurion 7 M12, Azurion 7 M20, Azurion 7 M12, Azurion 7 M20, Azurion 5 M12, Azurion 5 M20; Product Code: 72246, 722001, 722003, 722006, 722010, 722012, 722015, 722016, 722018, 722022, 722023, 722026, 722028, 722033, 722035, 722043, 722078, 722079, 722223, 722224, 722227, 722228] [HKMD No.: 100205, 100206, 200480, 230373].
The manufacturer has identified a potential safety issue with the affected products having monoplane fixed ceiling mounted systems. The ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur. Although the cover is retained by a safety chain, if a collision were to occur the chain may also detach resulting in the cover falling on the patient, user, or bystander. According to the manufacturer, there have been 5 incidents where minor injuries, such as bruises or scratches, were reported.
The manufacturer will contact affected users to arrange for a Field Service Engineer visit to replace the L-arm rotation cover. Affected users should follow the action listed on the FSN issued by the manufacturer.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 Nov 2023