Recall Z-1460-2015— Eos Imaging Inc

Name: FDA recall Z-1460-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-17

Class II · Terminated

Class II FDA medical device recall by Eos Imaging Inc, initiated 2015-02-17, terminated 2017-05-31. It names one FDA 510(k) clearance: K123740. Product: EOS, Digital radiography system used in general radiographic examinations.. Reason: When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration..

Recalling firm: Eos Imaging Inc
Classification: Class II
Status: Terminated
Initiated: 2015-02-17
Terminated: 2017-05-31
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K123740 — EOSEos Imaging·cleared 2013-02-22

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

EOS, Digital radiography system used in general radiographic examinations.

Reason for recall

When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.

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