CLASS II Device recall · Reported 5 Jul 2017 · FDA Enforcement Report

Shimadzu RADspeed Pro recalled by Shimadzu Medical Systems Usa

Shimadzu Medical Systems Usa Com is recalling Shimadzu RADspeed Pro, distributed nationwide in the US. The recall was initiated on 23 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial No. 0162M4501 thru 0562M45103, 3ZC5C2A0C002 thru 3ZC5C1734001, D362M42902 thru 0562M41101, 41E733E69003, MP95A8F5A001 thru MP95A9F6B001

Quantity recalled1673 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2654-2017
FDA event ID: 77351
Recalling firm: Shimadzu Medical Systems Usa Com, Torrance, CA
Classification: Class II
Status: Terminated
Recall initiated: 23 May 2017
FDA classified: 29 Jun 2017
Reported: 5 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

23 May 2017	Recall initiated by company
29 Jun 2017	Classified by FDA	+37 days
5 Jul 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was 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

Nationwide Alaska Arkansas Arizona California Connecticut Florida Hawaii Illinois Indiana Kansas Louisiana Michigan Missouri Nebraska New Jersey New Mexico Nevada New York Ohio Oklahoma

Questions about this recall

Is Shimadzu RADspeed Pro recalled?

Yes. Shimadzu Medical Systems Usa Com recalled Shimadzu RADspeed Pro on 23 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2654-2017.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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