Recall Z-1489-2017— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1489-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-14

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2017-02-14, terminated 2017-12-18. It names one FDA 510(k) clearance: K993425. Product: Mevatron M2/Primus Mid-Energy PRIMUS HI. Reason: Software update.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-02-14
Terminated: 2017-12-18
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

Mevatron M2/Primus Mid-Energy PRIMUS HI

Reason for recall

Software update

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