Juno DFR X-ray system

FDA device recall Z-1079-2015 · posted 2015-03-06 · Terminated

Recall details

Recalling firm

Villa Radiology Systems LLC

Reason for recall

The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality

Action taken

Planned Action by the firm: 1. You will send out a customer notification letter that identified the software corrective actions and that indicates that these corrective actions will be provided to the end-user free of charge. 2. You will implement a corrective software patch so that kV and mA manual adjustments from the generator console are inhibited, and consequently no high-level control modality is allowed. In AERC, high-level control is already disabled. A Field Service Engineer is to implement the software patch according to the corrective action plan 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR The system shall be modified upgrading the generator power firmware which will inhibit the high-level control bringing the system into compliance. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. You will implement the corrective software patch to inhibit high-level control according to the corrective action plan by June 22, 2015. For further questions please 203.262-8836

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

KXJ

Quantity affected

30 units distributed in the US

Distribution

US Distribution to the states of: AZ, AL, CA, CO, CT, DC, FL, IA, IL, IN, MI, MD, MS, MA, MO, NY, OH, PA, UT, TN and TX.

Date initiated

2014-12-14

Date posted

2015-03-06

Date terminated

2017-03-16

Location

Oxford, CT

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