0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution ...
FDA Recall #Z-0263-2013 — Class II — October 28, 2011
Product Description
0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution 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.
Reason for Recall
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.
Recalling Firm
Shimadzu Medical Systems — Torrance, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
133 units
Distribution
US Nationwide Distribution
Code Information
S/N of X-ray tube: 64510 66036 66026 66027 71866 70641 72470 72740 72735 73360 73365 2XY0084531 73372 73679 73671 73966 74248 74258 74546 74548 74291 74556 74832 74834 74833 74829 74837 76058 76326 76069 76355 76364 76361 76356 76358 76363 76367 2XY0080666 80666 2XY0080650 2XY0080345 2XY0080649 2XY0080656 2XY0082453 2XY0082456 2XY0082461 2XY0082748 2XY0083039 2XY0075448 2XY0082750 2XY0083070 2XY0082778 2XY0083047 2XY0083058 2XY0083680 2XY0083627 2XY0083633 2XY0083951 2XY0084556
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated