Siemens Medical Solutions USA, Inc recalls
17 recalls on record · 2 rated Critical · FDA
Every recall we have on record for Siemens Medical Solutions USA, Inc, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number…
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242,…
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Biograph mMR. Model Number: 10433372.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Sensis Vibe Hemo
The possibility of the Sensis documentation functionality application to crash.
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System.…
Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure
Luminos Agile Max (VE10, VF10, VF11)
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET…
In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for …
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Mechanical connection between the tabletop and table base may be lost.
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.
Artis zee floor MN, Model Number 10094142
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
Artis Q ceiling, Model Number 10848281
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
Artis Q zeego, Model Number 10848283
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
Artis Q.zen floor, Model Number 10848353
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option
SOMATOM Edge Plus-Computed tomography system Model 1026700
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and…
Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury