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.
Health Canada has posted a medical device safety alert concerning W.O.M. World of Medicine GmbH 1688 4k Camera Control Unit with Advanced Imaging Modality, Pneumoclear, Sdc3 HD Information Management System [Model or catalogue number: 1688010000, 0620050000, 0240060100; Lot or serial number: 20J536204, 19K514104, 2106CE0052, 2111CE0939, 2208CE1322, 1704CE0558, 2111CE0937, 2010CE0366, 2203CE0032, 16F013664, 18F576924, 17I534954, 16D029604, 18G546604] [HKMD No.: 170139, 200388].
According to Health Canada, Smart tags (Bluetooth powered tracking devices) were placed in multiple loaner devices manufactured by Stryker Endoscopy without undergoing verification and validation testing to ensure no adverse effect on product functionality.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/stryker-endoscopy-devices
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Aug 2023