FDA-Device2012-11-14Class II
0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Shimadzu Medical Systems
Hazard
Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Sold states
US Nationwide Distribution
Affected count
3 units
Manufactured in
20101 S Vermont Ave, N/A, Torrance, CA, United States
Products
0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0265-2013Don't want to check this manually?
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