FDAFDA · Food and drugs·Recall number Z-2654-2017
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
Published July 5, 2017 · Recall initiated: May 23, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Shimadzu Medical Systems Usa Com
- Distributor
- 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
- Lot
- Serial No. 0162M4501 thru 0562M45103, 3ZC5C2A0C002 thru 3ZC5C1734001, D362M42902 thru 0562M41101, 41E733E69003, MP95A8F5A001 thru MP95A9F6B001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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