Recall Z-2160-2013— Villa Radiology Systems LLC

Name: FDA recall Z-2160-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-02

Class II · Terminated

Class II FDA medical device recall by Villa Radiology Systems LLC, initiated 2013-08-02, terminated 2016-07-25. It names one FDA 510(k) clearance: K050190. Product: Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures. Reason: It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6.

Recalling firm: Villa Radiology Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2013-08-02
Terminated: 2016-07-25
Firm location: Oxford, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K050190 — APOLLOVilla Sistemi Medicali S.P.A.·cleared 2005-03-25

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

Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

Reason for recall

It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6

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