Recall Z-1469-2023— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1469-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-21

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2023-03-21. It names one FDA 510(k) clearance: K133580. Product: ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600. Reason: Examination room monitor connected with the hybrid cable may have a display issue and no image function is available.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-03-21
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K133580 — ARTIS ONESiemens Medical Solutions USA, Inc.·cleared 2014-04-28

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 one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600

Reason for recall

Examination room monitor connected with the hybrid cable may have a display issue and no image function is available

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