Recall Z-2306-2018— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2306-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-01

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-05-01, terminated 2019-05-16. It names one FDA 510(k) clearance: K123529. Product: Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures.. Reason: After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-05-01
Terminated: 2019-05-16
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K123529 — ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEMSiemens Medical Solutions USA, Inc.·cleared 2013-02-26

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

Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures.

Reason for recall

After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.

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