Recall Z-0260-2013 ยท IZW Collimator, Automatic, Radiographic
Shimadzu Medical Systems
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.
| Date | Nov 8, 2012 (initiated Oct 28, 2011) |
| Status | Terminated |
| 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. |
| 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 | 665 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090578 | SHIMADZU COLLIMATOR R-30H Shimadzu Corp., Nov 6, 2009 |