Other Medical Devices

Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs

Procedure packs contained a recalled product.

Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.

One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.

There are 7 reported software anomalies that may affect use of the device.

Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.

Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Added 1/3/2023), Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.

The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.

Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.

The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.

The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.

Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs