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The recall is being done because the device does not meet the requirements of the MDR. Specifically, the devices implanted are not on the device system's active license 104252. Recall start date: March 1, 2023

If the walker isn't being used as per original design, (e.g. if the chest pad with stem is omitted or is extended beyond capacity to allow for sufficient holding), and the screw is loose, the Pommel may fall off, potentially resulting in a fall.…

Freestyle Libre 2 Application (app) users on the Android 13 Operating System (OS), with alarms enabled, may experience situations of extended bluetooth connection loss which results in persistent signal loss conditions preventing glucose alarm function.…

Results of post market surveillance revealed that under certain circumstances the room configuration parameters of the system are set to default values. If these values are larger than the actual room dimensions, a collision with the ceiling or wall…

It was identified that two (2) Freestyle Libre sensor reel lots manufactured by Abbott Diabetes Care (ADC) failed retain testing. As a result of the investigation and testing of retains, the sensors were found to give clinically significant readings…

Siemens Healthcare is information customers of a potential issue with the Artis system in combination with a Siemens Healthineers table or a Trumpf/Maquet table. There are 3 potential issues depending on the combination of the Artis Pheno and type of…

Stryker has identified that there is a potential that the affected device was shipped with the incorrect language configuration. Recall start date: January 26, 2023

Momcozy wearable breast pumps were sold in the Canadian market without the proper authorization (i.e., medical device licence [MDL]). Recall start date: January 28, 2023

Baxter Corportation is issuing a recall for certain lots of the Minicap. These devices are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals.  Recall start date: February 01, 2023

The manufacturer of Statis SL handpieces has informed SciCan that the product may not function as expected if not properly maintained. When using the Statis handpieces, the lack of care or age-related wear and tear could result in the loosening parts…

Manufacturer initiated recall notifying users of variability of only the level 1 troponin I values included in the Mas CardioImmune XL controls (confirmed after 8 complaints). The level 1 control is included in lots of control kits CAI-XL 1, CAI-XL4…

Siemens Healthcare Diagnostics Inc. has confirmed through customer complaints the potential for functional sensitivity to not meet instructions for use (IFU) claims with the kit lots listed in table 1. Additionally, immulite thyroglobulin control module…

In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. The full system functionality is not available. Only the backup mode is available, as mentioned in the operator manual. The Syngo start-…

During transversal table movement, it could happen that the rolling bearing which is part of the linear guide rail and enables the transversal table movement may get dislocated. The rolling bearing may fall out of the linear guide rail and thus the…

Sporadically, the distance measurement values displayed in MRI images on third-party postprocessing systems might be wrong if: - enhanced MRI images with rectangular FOV (field of view) are created at the MR scanner, and - in Syngo.via or MR view&…