Z-0466-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 12, 2012
- Initiation Date
- October 18, 2012
- Termination Date
- July 8, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series
Product Description
NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
Reason for Recall
The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.
Distribution Pattern
Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico.
Code Information
NeuViz 16 system Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120022, N16E120020, N16E120023, N16E120024. Neuviz Dual Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013.