Siemens Medical Solutions USA Recalls

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

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

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

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

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

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

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

Hazard: Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data.

Hazard: Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis.

Hazard: During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.

Hazard: When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.

Hazard: under certain circumstances the Cios Alpha system may freeze during a procedure.

Hazard: A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.

Hazard: A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.

Hazard: There exists a possible position sensor fault in the swivel base axis not being detected by the system software. When moving, the system could potentially exceed its usual speed, resulting in a collision. No injuries reported.

Hazard: measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.

Hazard: A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching feature, leading to diagnosis delay.

Hazard: Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.

Hazard: Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.

Hazard: Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.

Hazard: Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.

Hazard: Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.

Hazard: Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.

Hazard: Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.

Hazard: In certain situations, loss of post exercise images can occur in Stress Echo.

Hazard: If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.

Hazard: In some cases, the system is unable to capture a clip or image during a routine scan.

Hazard: potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connection in the equipment cabinet has not been installed correctly. The potentially defective connection in the equipment cabinet will be inspected and, if necessary, corrected.

Hazard: Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.

Hazard: The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur.