Z-0261-2013Class II

R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85...

Name: Z-0261-2013 R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85...
Creator: Shimadzu Medical Systems
Published: 2011-10-28
License: https://open.fda.gov/license/

Shimadzu Medical Systems / initiated 2011-10-28 / Terminated / root cause: manufacturing process

FDA source

Shimadzu Medical Systems began a recall of 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... on 2011-10-28. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0261-2013
Classification: Class II
Status: Terminated
Initiated: 2011-10-28
Posted: 2012-11-08
Terminated: 2016-07-26
Recalling firm: Shimadzu Medical Systems
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.
Product code: IZX Collimator, Manual, Radiographic
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Shimadzu sent an Urgent Voluntary Medical Device Recall - Field Safety Notice letters dated September 19, 2012 to all the affected customers. The letter identifed the description of non-compliance, how to identify the affected products, corrective action plan by Shimadzu and actions to be taken customers. Customers were instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at Shimadzu Medical Systems National Technical Support (800) 228-1429.
Quantity in commerce: 308 units
Distribution: US Nationwide Distribution
Product codes and lots: Device Model #R-20J

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0261-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0260-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-07
Z-0261-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-07
Z-0262-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-07
Z-0263-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-07
Z-0264-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-07
Z-0265-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-07

Product code IZX

K101036Class IIShimadzu Collimator R-20JShimadzu Corp. / cleared 2010-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)