Recall Z-3189-2018— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-3189-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-29

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-07-29, terminated 2019-05-17. It names one FDA 510(k) clearance: K123529. Product: Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355. Reason: Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night)..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-07-29
Terminated: 2019-05-17
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 Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355

Reason for recall

Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).

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