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During a ventilation sequence, the user started the "100% O2" function. This function lasts for two minutes but can be interrupted by pressing the 100% O2 key. Note: after the 100% O2 function has been used, the FiO2 setpoint originally entered is…

The instructions for use (IFU) for the Pneumostat Chest Drain Valve and for the Express Mini 500 do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning…

During internal testing, regulatory compliance issues regarding fluid ingress and basic safety issues have been identified with the Tempus Pro monitor, ac mains power supply, and the vehicle adaptor. the tempus pro device's labeling indicates that the…

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…

The affected products were manufactured using unvalidated materials that can result in unsealed packaging for the individual syringes. Recall start date: February 3, 2023

This medical device recall (correction) has been initiated due to certain lots labeled with incorrect expiration dates. The labeled expiration dates of impacted products were printed with a 10-year expiration date however, the products have an…

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

During internal studies with the Elecsys® Troponin T hs (high sensitive) and Elecsys® Troponin T hs Stat assays, it was confirmed that for certain k2/k3 EDTA primary tubes, TnT hs results are elevated compared to serum samples when measured…

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…

Importation and sale of an unlicensed class II medical device. Recall start date: December 20, 2022

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-…