Recall Z-1311-2023— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1311-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-02

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2023-02-02. It names one FDA 510(k) clearance: K163286. Product: ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.. Reason: In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-02-02
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K163286 — ARTIS phenoSiemens Medical Solution USA, Inc.·cleared 2017-03-09

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 pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

Reason for recall

In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.

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