Shimadzu Medical Systems Usa Com: Medical Device Recall in 2017 - (Recall #: Z-2654-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system

Product Classification:

Class II

Date Initiated: May 23, 2017

Date Posted: July 5, 2017

Recall Number: Z-2654-2017

Event ID: 77351

Reason for Recall:

Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.

Status: Terminated

Product Quantity: 1673 units total

Code Information:

Serial No. 0162M4501 thru 0562M45103, 3ZC5C2A0C002 thru 3ZC5C1734001, D362M42902 thru 0562M41101, 41E733E69003, MP95A8F5A001 thru MP95A9F6B001

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated