Recall Z-0692-2017— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0692-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-20

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-10-20, terminated 2017-05-30. It names one FDA 510(k) clearance: K133589. Product: SOMATOM Force, System x-ray, tomography, computed. Reason: Siemens is providing software update version VA50A_SP3 to address the software bugs that were identified through normal field monitoring and the Global Complaint Handling Process. Correction for the problems are as follows: 1. Correction to volumetric misrepresentations of high contrast objects when using ADMIRE. 2. Correction to highly sporadic scan aborts due to temporarily tube currents at 0mA. 3. Correction to missing Microsoft Hotfixes (MS16-001, MS15-135, MS15-088, MS15-048). 4. Correction to highly sporadic image artifacts caused by error signals from high voltage chain at extremely high tube currents. 5. Correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed. 6. Correction to highly sporadic scan aborts due to temporarily high disk load of system disk. 7. Correction to highly sporadic image artifacts generated by scatter correction in case of tube arcings..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-10-20
Terminated: 2017-05-30
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K133589 — SOMATOM FORCESiemens Medical Solutions USA, Inc.·cleared 2014-04-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SOMATOM Force, System x-ray, tomography, computed

Reason for recall

Siemens is providing software update version VA50A_SP3 to address the software bugs that were identified through normal field monitoring and the Global Complaint Handling Process. Correction for the problems are as follows: 1. Correction to volumetric misrepresentations of high contrast objects when using ADMIRE. 2. Correction to highly sporadic scan aborts due to temporarily tube currents at 0mA. 3. Correction to missing Microsoft Hotfixes (MS16-001, MS15-135, MS15-088, MS15-048). 4. Correction to highly sporadic image artifacts caused by error signals from high voltage chain at extremely high tube currents. 5. Correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed. 6. Correction to highly sporadic scan aborts due to temporarily high disk load of system disk. 7. Correction to highly sporadic image artifacts generated by scatter correction in case of tube arcings.

Data sourced from openFDA. This site is unofficial and independent of the FDA.