Recall Z-0261-2013— Shimadzu Medical Systems

Name: FDA recall Z-0261-2013
Creator: U.S. Food and Drug Administration
Published: 2011-10-28

Class II · Terminated

Class II FDA medical device recall by Shimadzu Medical Systems, initiated 2011-10-28, terminated 2016-07-26. It names one FDA 510(k) clearance: K101036. Product: R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography.. Reason: 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
Classification: Class II
Status: Terminated
Initiated: 2011-10-28
Terminated: 2016-07-26
Firm location: Torrance, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K101036 — SHIMADZU COLLIMATOR R-20JShimadzu Corp.·cleared 2010-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.