Recall Z-1893-2017— Ziehm Imaging Inc

Name: FDA recall Z-1893-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-23

Class II · Terminated

Class II FDA medical device recall by Ziehm Imaging Inc, initiated 2017-02-23, terminated 2019-12-11. It names one FDA 510(k) clearance: K161976. Product: Ziehm Imaging solo FD Mobile Fluoroscopic C-arm. Reason: During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component.

Recalling firm: Ziehm Imaging Inc
Classification: Class II
Status: Terminated
Initiated: 2017-02-23
Terminated: 2019-12-11
Firm location: Orlando, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K161976 — Ziehm Solo FDZiehm Imaging GmbH·cleared 2016-10-06

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

Ziehm Imaging solo FD Mobile Fluoroscopic C-arm

Reason for recall

During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component

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