Device Recall Juno DFR Xray system 의 리콜

Recall

70241

Class 2

Z-1079-2015

2014-12-14

2015-03-06

Terminated

United States

2017-03-16

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132618

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

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