Recall Z-0775-2023— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0775-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-16

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2022-11-16. It names one FDA 510(k) clearance: K150493. Product: Programmable Diagnostic Computer. Reason: The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE CORRUPTED" error message during system boot; 2) Subsystem crash during examination; 3) Dialog Monitor Computer (DMC) application crash while loading a study; and 4) Software crash due to system internal timeout. Issue 1 may lead to a delay or interruption of procedure. Issues 2, 3, and 4 may result in delay in starting or continuing the examination, and may also prevent the operator from starting or continuing a study;.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-11-16
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K150493 — SensisSiemens Medi Cal Solutions, Inc.·cleared 2015-06-30

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

Programmable Diagnostic Computer

Reason for recall

The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE CORRUPTED" error message during system boot; 2) Subsystem crash during examination; 3) Dialog Monitor Computer (DMC) application crash while loading a study; and 4) Software crash due to system internal timeout. Issue 1 may lead to a delay or interruption of procedure. Issues 2, 3, and 4 may result in delay in starting or continuing the examination, and may also prevent the operator from starting or continuing a study;

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