Siemens Medical Solutions USA Recalls

Hazard: Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region is now properly fitted to segment boundary when clicking fit breast to screen.

Hazard: Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.

Hazard: To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished and shipped to the customer.

Hazard: Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted gantry. In a 2x2 layout, the 4D tabcard will show an incorrect, too small length measurement. This could result in selecting a device of the wrong size, which then needs to be exchanged.

Hazard: For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo Imaging XS printer configuration file.

Hazard: Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening.

Hazard: Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench line may cause the helium gas to be blown directly into the magnet room or other areas. This could lead to displacement of oxygen, cause cold burns, and/or pose a risk to users, patient or others.

Hazard: To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D.

Hazard: Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.

Hazard: Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a defective brake to engage in the unpowered state by applying a reverse charge to the brake and ensuring the brake has demagnetized.

Hazard: Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware configuration). Hardware fixes will be implemented to address situations where the metal component used to engage the wheel lock becomes disconnected, and where the system locks up due to misalignment between the bezel and MPI board, in all units that have not already been corrected.

Hazard: potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto Field Sequence Option.

Hazard: patient procedure interruption due to a potential system failure

Hazard: Software and firmware bugs

Hazard: This update is intended to provide a software update for the Syngo RT Oncologist, which is currently running SW version 4.2 or 4.3. The safety-related issues, which were described in the Customer Safety Notice distributed as UFSN-RTT/RTO 4.3 Adaptive Targeting [Auto-registration]. The update contains several important safety and performance fixes.

Hazard: software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin

Hazard: software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin

Hazard: software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin

Hazard: A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.

Hazard: The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. If these differences are not corrected at the time of registration, the system does not capture images or clips.

Hazard: Potential issue leading to data loss and patient data mix-up

Hazard: Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.

Hazard: Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.

Hazard: Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.

Hazard: in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to either resolve the root cause of the system being in "Bypass Fluoro" or to restart the system.

Hazard: When using the CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guidelines, the biopsy needle may traverse outside the on-screen guidelines.

Hazard: The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.

Hazard: The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.

Hazard: The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.

Hazard: Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.