FDA Enforcement
Class II
Terminated
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.
Recall: Z-0261-2013
·
Reported November 14, 2012
Enforcement
- Recall Number
- Z-0261-2013
- Event ID
- 62271
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Shimadzu Medical Systems
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 14, 2012
- Initiation Date
- October 28, 2011
- Classification Date
- November 7, 2012
- Termination Date
- July 26, 2016
- Address
- 20101 S Vermont Ave, N/A, Torrance, CA, 90502-1328, United States
Description
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.
Code Info
Device Model #R-20J
Distribution
US Nationwide Distribution
Quantity
308 units