Reported Nov 14, 2012 · Terminated
0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of…
Shimadzu Medical Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shimadzu Medical Systems · 20101 S Vermont Ave · Torrance, CA · 90502-1328
Is this the product you have?
- 0.4/0.7JG326D-265AX/AT
- Product UsageThe 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
- Lot codes and dates
- S/N of X-ray tube
71 of 71 codes
2XY00847252XY00847242XY00847232XY00996982XY00847262XY00847362XY00847392XY00848692XY00847292XY00848682XY00851622XY00851752XY00863832XY00863952XY00867262XY00867252XY00867242XY00870862XY00870882XY00870902XY00874212XY00874232XY00874272XY00877652XY00907472XY00910752XY00938942XY00962982XY00968202XY00968212XY00968322XY00962922XY00982452XY00982402XY00010642XY00011952XY00010882XY00012082XY00010772XY00010862XY00011982XY00013212XY00012042XY00013362XY00013372XY00013522XY00013882XY00013152XY00013702XY00013802XY00014642XY00014822XY00014842XY00014852XY00027302XY00030422XY00030372XY0003759CM74B3016024CM74B3017067
- S/N of X-ray tube
- Amount recalled
- 3 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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