Recall Z-0787-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0787-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-05

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-12-05, terminated 2015-01-30. It names one FDA 510(k) clearance: K050422. Product: PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.. Reason: Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 TxT Treatment Table. Combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the TxT" Treatment Table has been damaged due to contacting a moving part. The resulting short-circuit cau.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-12-05
Terminated: 2015-01-30
Firm location: Martinez, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K050422 — 550 TXT TREATMENT TABLESiemens Medical Solutions USA, Inc.·cleared 2005-03-18

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

PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

Reason for recall

Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 TxT Treatment Table. Combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the TxT" Treatment Table has been damaged due to contacting a moving part. The resulting short-circuit cau

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