Search

This voluntary medical device correction is being taken following the investigation of six customer reports stating that a total of four ventilators became inoperable during use. One of these reports indicated that, following the ventilator becoming…

Hillrom service team has identified that during an audio station's rebooting sequence, which may occur during a system upgrade/planned service event, or with an emergency power outage, where back up power is not functioning, the audio…

These products are being recalled because of a potential leak due to a weak seam at the upper middle seam near the nose wire. Not all of the products are affected, but to ERR on the side of caution all masks that were produced between…

There is potential patient fall hazards could occur when the PHS pallet/foot extension is improperly assembled by the operator. PHS pallet/foot extension patient fall hazards could occur when the extension is improperly used to position…

There is potential patient fall hazards could occur when the PHS pallet/foot extension is improperly assembled by the operator. PHS pallet/foot extension patient fall hazards could occur when the extension is improperly used to position…

The manufacturer confirmed that some SARS-COV-2  Rapid Antigen Test Nasal kits lots were erroneously distributed with Medico swabs, which are not included in the current Health Canada interim order authorization for that kit.…

Jjsv inc. Is issuing this recall notice due to a cybersecurity vulnerability for Idesign Systems Catalys Precision laser systems utilizing microsoft windows operating systems and the print spooler functionality. The vulnerability is a…

The importer was informed that the specifications do not meet the requirements or the laboratories were not reliable/verifiable. Not all respirators meet the minimum 95% filtration rate required. Recall start date: 2021-05-28…

Power wheelchairs with a linx Gyro component running firmware version 6.1.2 Can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile. Recall start…

Roche received few complaints from customers reporting the generation of false mutation detected results for the Exon 20 insertion (EX20INS) mutation when using the Cobas EGFR mutation test V2. Recall start date: 2021-09-15…

A problem has been identified in the Philips Allura Xper and Azurion systems that could pose a risk for patients. Philips has discovered that the wireless foot switch can suddenly stop responding due to a firmware bug when a number of ambient conditions…

Respirator requires a disclaimer that it is not NIOSH N95 and to include a unique identifier for each model on the packaging.   Recall start date: 2021-10-27…

For products affected, the required sterility assurance level was not achieved during recent testing of the sterilization process performed by the contract sterilizer. The testing was initiated as a result of a regular re-qualification…

These respirators do not meet the prescribed standard of KN95. There is insufficient evidence to support their safety and effectiveness. This recall affects Hynaut KN95 protective face mask models C004, C012, A048, A058, and A059…

MRI images with certain values in the Dicom tags rescale slope (0028,1053) and rescale intercept (0028, 1052) can show wrong statistical values 'min/max' (maximum and minimum grayscale value in the ROI) and 'Mean/STD D' (mean value and…