Company: Villa Radiology Systems LLC.
Date of Enforcement Report 3/18/2015
Class lI:
PRODUCT
Juno DFR x-ray system
Recall Number Z-1079-2015
REASON
It has been discovered that the system – does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
RECALLING FIRM/MANUFACTURER
Villa Radiology Systems LLC, Oxford, CT. 12/14/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
30
DISTRIBUTION
Nationwide
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