Enforcement Report - Week of November 14, 2012
-
Back to Previous Page
Product Detail
| Product Description | R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting device for X-ray Radiography. |
|---|---|
| Recall Number | Z-0260-2013 |
| Classification | Class II |
| Code Info | Device Model #R-30H |
| Product Distributed Qty | 665 units |
| 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. |
Event Detail
| Event Id | 62271 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Shimadzu Medical Systems |
| City | Torrance |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-10-28 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | US Nationwide Distribution |
-
