Shimadzu Medical Systems Usa Com recalls SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
- Recall date
- May 23, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2654-2017
- FDA classification
- Class II
- Brand / firm
- Shimadzu Medical Systems Usa Com
- Sold / distributed
- Worldwide Distribution - Nationwide distribution to AK, AR, AZ, CA, CT, FL, IL, IN, KS, LA, MI, MO, NE, NJ, NM, NV, NY,OH, OK, PA, RI, SC, TN, TX, WA, WI, and Hawaii Foreign: Canada and Japan
Why it was recalled
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
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