CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report
R-20J , Diagnostic X-Ray Beam-Limiting Device recalled
Shimadzu Medical Systems is recalling R-20J , Diagnostic X-Ray Beam-Limiting Device, distributed nationwide in the US. The recall was initiated on 28 Oct 2011 and the FDA has classified it as Class II.
Check your package
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-0261-2013
- FDA event ID
- 62271
- Recalling firm
- Shimadzu Medical Systems, Torrance, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Oct 2011
- FDA classified
- 7 Nov 2012
- Reported
- 14 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 28 Oct 2011 | Recall initiated by company | |
| 7 Nov 2012 | Classified by FDA | +376 days |
| 14 Nov 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it 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.
Which lots are affected?
Device Model #R-20J
Where was it sold?
US Nationwide Distribution
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 62271This product is part of a recall event; the main page for the event is MUX-100H. Classification Name: Mobile x-ray system. Device recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | MUX-100H. Classification Name: Mobile x-ray system. Device recalled | Shimadzu Medical Systems | Other | Nationwide | |
| CLASS II | 0.7/1.3U163CS- combination with below systems MobileArt recalled | Shimadzu Medical Systems | Other | Nationwide | |
| CLASS II | 0.4/0.7jg326d-265ax/at recalled by Shimadzu Medical Systems | Shimadzu Medical Systems | Other | Nationwide | |
| CLASS II | 0.7/1.2jg326d recalled by Shimadzu Medical Systems | Shimadzu Medical Systems | Other | Nationwide | |
| CLASS II | R-30H , Diagnostic X-Ray Beam-Limiting Device recalled | Shimadzu Medical Systems | Other | Nationwide |
More recalls from Shimadzu Medical Systems
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Model: X-ray R/F System FLUOROspeed X1 recalled | Shimadzu Medical Systems | Other | 37 states |
| Device | CLASS II | Model: X-ray TV System Sonialvision G4 recalled | Shimadzu Medical Systems | Other | 37 states |
| Device | CLASS II | Model: X-ray TV Sysstem Sonialvision safire17 recalled | Shimadzu Medical Systems | Other | 37 states |
| Device | CLASS II | Digital Angiography System Shimadzu Trinias Generator recalled | Shimadzu Medical Systems | Other | 15 states |
| Device | CLASS II | Digital Angiography System Bransist safire Generator recalled | Shimadzu Medical Systems | Other | 15 states |
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| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |