FDA Enforcement
Class II
Terminated
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
Recall: Z-2654-2017
·
Reported July 5, 2017
Enforcement
- Recall Number
- Z-2654-2017
- Event ID
- 77351
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Shimadzu Medical Systems Usa Com
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 5, 2017
- Initiation Date
- May 23, 2017
- Classification Date
- June 29, 2017
- Termination Date
- October 1, 2019
- Address
- 20101 S Vermont Ave, N/A, Torrance, CA, 90502-1328, United States
Description
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
Reason
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Code Info
Serial No. 0162M4501 thru 0562M45103, 3ZC5C2A0C002 thru 3ZC5C1734001, D362M42902 thru 0562M41101, 41E733E69003, MP95A8F5A001 thru MP95A9F6B001
Distribution
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
Quantity
1673 units total