FDA Device recall Z-0261-2013
R-20J , Diagnostic X-Ray Beam-Limiting Device
- FDA Device
- Class II
- terminated
- Published 2012-11-14
On 2012-11-14 the FDA classified a Class II recall of R-20J , Diagnostic X-Ray Beam-Limiting Device by Shimadzu Medical Systems, citing 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 Standar….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0261-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-10-28 |
| Published | 2012-11-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Shimadzu Medical Systems |
| Distribution | US |
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.
Identifiers
| code_info | Device Model #R-20J |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Shimadzu Medical Systems
- Digital Angiography System Trinias:UD150G-40 / D150GC-40
FDA Device · Class II · 2026-06-10 · Shimadzu Medical Systems - MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
FDA Device · Class II · 2022-04-13 · Shimadzu Medical Systems - MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
FDA Device · Class II · 2022-04-13 · Shimadzu Medical Systems - MODEL: X-RAY TV SYSTEM SONIALVISION G4
FDA Device · Class II · 2022-04-13 · Shimadzu Medical Systems - Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
FDA Device · Class II · 2022-03-09 · Shimadzu Medical Systems
All Shimadzu Medical Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0261-2013%22
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