Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
0.7U163CS-36 In combination with below systems MUX-100H Recalled by Shimadzu Medical Systems Due to Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Shimadzu Medical Systems directly.
Affected Products
0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Quantity: 288 units
Why Was This Recalled?
Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Shimadzu Medical Systems
Shimadzu Medical Systems has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report