Search

Affected lot exceeds concentration limit for N-nitrosodimethylamine (NDMA) at the 48-month stability testing timepoint.

Affected lots may contain the presence of Cronobacter contamination.

Affected lots may contain the presence of foreign matter.

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…

Presence of particulate matter in affected lot.

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-…

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&…

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…

Siemens Healthcare is informing customers with a preventive measure to exclude any potential risk of patient injury caused the footrest detaching from the patient table during an examination. Recall start date: December 15, 2022

Siemens Healthcare Diagnostics Inc. has confirmed an issue through complaint investigation. The issue has the potential to affect the recovery of po2 in quality control (qc) at elevation with barometric pressures <730 mmhg on epoc sensor configuration…