Medical Devices Recalls

Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.

Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects

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.

The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 being erased. Due to this issue, the target RPM for the assay is 0 and the motor output required to achieve this RPM is also 0. Therefore, when the assay is run, the software applies 0 Volts to the motor and performs a 0 RPM assay. Because of this, there is no mixing of the blood with agonist and no moving of aggregates happens in front of the optical detectors. The resulting PAI is 0 and the result is displayed as Low.

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.

Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects

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

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.

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.

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.

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

There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects

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

There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

Some of the devices did not pass fatigue testing.