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Recall is being initiated to notify customers to the risk of the use and installation of unauthorized, third-party parts on the Alaris system. Recall start date: Feb 7, 2022

Maquet Cardiopulmonary Gmbh has determined during the testing of a Cardiohelp-I, that the cylindrical pin in the upper part of the transport guard can come loose. the transport guard is an accessory of the Cardiohelp-I and secures the oxygenator to the…

Southmedic had engaged an alternative material supplier due to material shortages and was made aware on January 25, 2022 that manufactured and distributed Clearchoice foam face shields have the potential for the presence of latex in the elastic bands of…

Following an increase in reports to poison control centres, Health Canada is advising Canadians about potential risks associated with the misuse or accidental ingestion or spillage of COVID-19 rapid antigen test kit solutions on the skin. Health Canada…

Since January 2021, based on complaints received from the field related to critical non-repeatable overestimated results (changing interpretation according to the cutoff value, 19 ng/l, in the frame of the three hours algorithm that lead to a change in…

As a result of Shimadzu investigation, it was determined that there is an issue with the adjustment procedure documented for the calibration of the system x-ray generator. This could cause x-ray radiation dose rate to exceed regulation and/or standards…

The esophageal/rectal/skin temperature probe's instructions for use, (IFU), contain inadequate instructions related to the cleaning and disinfection process for the reusable probes. The IFU instructs the user to clean the product with disinfecting agents…

Health Canada is advising patients who use MiniCap Extended Life Peritoneal Dialysis Transfer Sets, manufactured by Baxter Corporation, that direct contact between the sets and certain cleaning products, including hand sanitizers and solvents, may damage…

Positive, instead of negative, results have been reported by customers for the low control and patient samples for Quantum Blue® Anti-Infliximab production Series 1107. The increased false-positive rate was confirmed internally at Bühlmann. Approximately…

Investigations conducted at the manufacturing site identified that the lot may present an elevated risk of leakage from the air-inlet filter of the device. Recall start date: Jan 25, 2022

Investigations conducted at the manufacturing site identified that the lot may present an elevated risk of leakage from the air-inlet filter of the device. Recall start date: Jan 25, 2022

Post-implantation fracture of an internal metallic component (i.e., locking pin) had been observed in early version of Magec rods that were manufactured prior to March 26, 2015. In June 2019, Nuvasive Specialized Orthopedics issued a safety alert to…

If the Carescape Central Station v2.0 is used with an unapproved keyboard that contains a mute key, and if the mute key is pressed, the audio will be muted resulting in loss of audible alarms. this issue can result in a delay in noticing a change in…

Hillrom has become aware of a vulnerability which allows the entry of any username that is provisioned in the application without supplying a password. This will then grant access to the application with the privileges of the username provided. the…

While performing a review of product literature, including the instructions for use (IFU) and patient manual (PM), It was identified that additional clarity was required around cleaning the power source connectors (controller AC adapter, DC adapter, and…