Recall Z-1402-2018— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1402-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-14

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-02-14, terminated 2019-05-16. It names one FDA 510(k) clearance: K993425. Product: PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.. Reason: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-02-14
Terminated: 2019-05-16
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K993425 — PRIMUSSiemens Medical Solutions USA, Inc.·cleared 1999-11-26

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 HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.

Reason for recall

Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.

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