Device product
CIOS ALPHA; image intensified fluoroscopic x-ray system
Z-0118-2016
Product summary
- Event
- Event 72138
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44
- Official record key
device-enforcement:Z-0118-2016
Official wording
Reason: patient procedure interruption due to a potential system failure
Code information: model #10308191 with serial numbers: Serial 11032 10073 11132 11044 11005 10115 11056 10057 10076 10019 10035 11074 11075 11077 11083 11124 10078 11119 11103 11105 11013 10021 10037 10063 11106 10082 11098 11094 10089 11080 11009 11018 11082 10058 10098 11120 11134 11015 11016 11038 10116 11035 11107 11064
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
patient procedure interruption due to a potential system failure