Recall Z-1332-2022— Arcoma AB

Name: FDA recall Z-1332-2022
Creator: U.S. Food and Drug Administration
Published: 2021-05-05

Class II · Ongoing

Class II FDA medical device recall by Arcoma AB, initiated 2021-05-05. It names one FDA 510(k) clearance: K140683. Product: Omnera 400A Digital Radiographic System. Reason: There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC)..

Recalling firm: Arcoma AB
Classification: Class II
Status: Ongoing
Initiated: 2021-05-05
Firm location: Vaxjo, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K140683 — 0180 INTUITION, 0072 PRECISIONArcoma AB·cleared 2014-06-03

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

Omnera 400A Digital Radiographic System

Reason for recall

There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).

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