Device product
UroDiagnost; x-ray system. Product Code: 708033
Z-2306-2016
Product summary
- Event
- Event 74731
- Status
- Terminated
- Classification
- Class II
- Quantity
- 993 total
- Official record key
device-enforcement:Z-2306-2016
Official wording
Reason: The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag
Code information: All serial numbers. 708033 System serial numbers 1, 17, 15, 4, 3, 7, 18, 21, 8, 13, 14, 11, 5, 16, 2.
Distribution pattern: Worldwide distribution. US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.
Derived failure modes
-
Unknown
The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag