0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Enforcement
- Recall Number
- Z-0264-2013
- 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
0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
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.
MobileArt Evolution (12.5 kW) S/N of X-ray tube: 2XY0090049 2XY0090052 2XY0090062 2XY0090388 2XY0092824 2XY0092822 2XY0094944 2XY0094940 2XY0095628 2XY0095975 2XY0095996 2XY0097550 2XY0097539 2XY0000035 2XY0090058 MobileArt Evolution (32 kW) S/N of X-ray tube: 2XY0092847 2XY0092851 2XY0092850 2XY0093893 2XY0093890 2XY0093561 2XY0096822 2XY0096828 2XY0097579 2XY0000834 2XY0001079 2XY0001215 2XY0001200 2XY0001311 2XY0001216 2XY0001312 2XY0001214 2XY0001377 2XY0001374 2XY0001383 2XY0001488 2XY0001653 2XY0001478 2XY0001657 2XY0001658 2XY0001674 2XY0001672 2XY0001644 2XY0002081 2XY0002281 2XY0002088 2XY0002083 2XY0002289 2XY0001827 CM74B3012026 2XY0003774 2XY0004043
US Nationwide Distribution
5 units