Z-0694-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 3, 2016
- Initiation Date
- December 18, 2015
- Termination Date
- March 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 253 units
Product Description
Fuse 1C Colonoscope
Reason for Recall
The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.
Distribution Pattern
Worldwide Distribution. US nationwide, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia, Republic of Korea, Spain and Switzerland.
Code Information
Item number: FSC-3300-SL, Model number: C38s, Serial numbers: F1C0218FUSE1CS, F1C0219FUSE1CS, F1C0220FUSE1CS, F1C0221FUSE1CS, F1C0222FUSE1CS, F1C0223FUSE1CS, F1C0224FUSE1CS, F1C0225FUSE1CS, F1C0228FUSE1CS, F1C0229FUSE1CS, F1C0230FUSE1CS, F1C0231FUSE1CS, F1C0232FUSE1CS, F1C0233FUSE1CS, F1C0235FUSE1CS, F1C0236FUSE1CS, F1C0237FUSE1CS, F1C0238FUSE1CS, F1C0239FUSE1CS, F1C0241FUSE1CS, F1C0243FUSE1CS, F1C0245FUSE1CS, F1C0246FUSE1CS, F1C0247FUSE1CS, F1C0248FUSE1CS, F1C0249FUSE1CS, F1C0250FUSE1CS, F1C0251FUSE1CS, F1C0252FUSE1CS, F1C0253FUSE1CS, F1C0254FUSE1CS, F1C0255FUSE1CS, F1C0256FUSE1CS, F1C0257FUSE1CS, F1C0258FUSE1CS, F1C0259FUSE1CS, F1C0261FUSE1CS, F1C0262FUSE1CS, F1C0263FUSE1CS, F1C0264FUSE1CS, F1C0266FUSE1CS, F1C0267FUSE1CS, F1C0268FUSE1CS, F1C0269FUSE1CS, F1C0270FUSE1CS, F1C0271FUSE1CS, F1C0272FUSE1CS, F1C0273FUSE1CS, F1C0274FUSE1CS, F1C0276FUSE1CS, F1C0277FUSE1CS, F1C0278FUSE1CS, F1C0279FUSE1CS, F1C0280FUSE1CS, F1C0281FUSE1CS, F1C0282FUSE1CS, F1C0284FUSE1CS, F1C0285FUSE1CS, F1C0287FUSE1CS, F1C0288FUSE1CS, F1C0289FUSE1CS, F1C0290FUSE1CS, F1C0291FUSE1CS, F1C0292FUSE1CS, F1C0293FUSE1CS, F1C0294FUSE1CS, F1C0296FUSE1CS, F1C0297FUSE1CS, F1C0298FUSE1CS, F1C0299FUSE1CS, F1C0300FUSE1CS, F1C0301FUSE1CS, F1C0305FUSE1CS ; Item number: FSC-330-C6333, Model number: C38s-150, Serial numbers: 0600200, 0600201, 0600202, 0600203, 0600204, 0600205 and 0600206; Item number: FSC-3300-ST, Model number: F1C, Serial numbers: F1C0214FUSE1C-150F1C0241FUSEC1, F1C0244FUSE1C-A, F1C0244FUSEC1, F1C0255FUSE1C-A, F1C0259FUSE1C, F1C0271FUSE1C, F1C0283FUSE1C, F1C0312FUSE1C, F1C0313FUSE1C, F1C0322FUSE1C, F1C0334FUSE1C, F1C0356FUSE1C, F1C0382FUSE1C, F1C0388FUSE1C, F1C0425FUSE1C, F1C0433FUSE1C, F1C0437FUSE1C, F1C0447FUSE1C, F1C0449FUSE1C, F1C0458FUSE1C, F1C0461FUSE1C, F1C0475FUSE1C, F1C0479FUSE1C, F1C0484FUSE1C, F1C0488FUSE1C, F1C0489FUSE1C, F1C0516FUSE1C, F1C0526FUSE1C, F1C0530FUSE1C, F1C0531FUSE1C, F1C0536FUSE1C, F1C0537FUSE1C, F1C0540FUSE1C, F1C0542FUSE1C, F1C0543FUSE1C, F1C0544FUSE1C, F1C0545FUSE1C, F1C0546FUSE1C, F1C0547FUSE1C, F1C0549FUSE1C, F1C0584FUSE1C, F1C0586FUSE1C, F1C0603FUSE1C, F1C0640FUSE1C, F1C0660FUSE1C, F1C0668FUSE1C, F1C0691FUSE1C, F1C0692FUSE1C, F1C0693FUSE1C, F1C0694FUSE1C, F1C0709FUSE1C, F1C0714FUSE1C, F1C0736FUSE1C, F1C0739FUSE1C, F1C0742FUSE1C, F1C0745FUSE1C, F1C0749FUSE1C, F1C0758FUSE1C, F1C0763FUSE1C, F1C0765FUSE1C, F1C0767FUSE1C, F1C0776FUSE1C, F1C0778FUSE1C, F1C0779FUSE1C, F1C0786FUSE1C, F1C0790FUSE1CL, F1C0791FUSE1CL, F1C0794FUSE1C, F1C0796FUSE1C, F1C0799FUSE1C, F1C0800FUSE1CL, F1C0802FUSE1C, F1C0806FUSE1C, F1C0811FUSE1C, F1C0812FUSE1C, F1C0814FUSE1C, F1C0817FUSE1C, F1C0818FUSE1C, F1C0825FUSE1C, F1C0827FUSE1C, F1C0828FUSE1C, F1C0829FUSE1C, F1C0831FUSE1C, F1C0833FUSE1C, F1C0834FUSE1C, F1C0835FUSE1C, F1C0837FUSE1C, F1C0838FUSE1C, F1C0841FUSE1C, F1C0849FUSE1C, F1C0852FUSE1C, F1C0857FUSE1C, F1C0858FUSE1C, F1C0859FUSE1C, F1C0860FUSE1C, F1C0862FUSE1C, F1C0863FUSE1C, F1C0864FUSE1C, F1C0866FUSE1C, F1C0867FUSE1C, F1C0868FUSE1C, F1C0870FUSE1C, F1C0871FUSE1C, F1C0872FUSE1C, F1C0873FUSE1C, F1C0874FUSE1C, F1C0875FUSE1C, F1C0876FUSE1C, F1C0878FUSE1C, F1C0879FUSE1C, F1C0880FUSE1C, F1C0883FUSE1C, F1C0884FUSE1C, F1C0885FUSE1C, F1C0893FUSE1C, F1C0894FUSE1C, F1C0895FUSE1C, F1C0898FUSE1C, F1C0900FUSE1C, F1C0902FUSE1C, F1C0905FUSE1C, F1C0906FUSE1C, F1C0907FUSE1C, F1C0908FUSE1C, F1C0910FUSE1C F1C0921FUSE1C; Item number: FSC330-A6334, Model number: F1C-MC90, Serial numbers: 0700200, 0700204, 0700205, 0700207, 0700209, 0700210, 0700212, 0700215 and 0700217; Item number: FDC-3300-133, Model number: Fuse Colo 133, Serial numbers: F1C0201FUSE1C-133, F1C0202FUSE1C-133, F1C0203FUSE1C-133, F1C0204FUSE-133, F1C0205FUSE1C-133, F1C0206FUSE1C-133, F1C0207FUSE1C-133, F1C0208FUSE1C-133, F1C0209FUSE1C-133, F1C0210FUSE1C-133, F1C0211FUSE1C-133, F1C0216FUSE1C-133, F1C0217FUSE1C-133, F1C0218FUSE1C-133, F1C0219FUSE1C-133, F1C0221FUSE1C-133, F1C0222FUSE1C-133, F1C0223FUSE1C-133, F1C0224FUSE1C-133, F1C0225FUSE1C-133, F1C0226FUSE1C-133, F1C0227FUSE1C-133, F1C0228FUSE1C-133, F1C0229FUSE1C-133, F1C0230FUSE1C-133, F1C0235FUSE1C-133 and Item number: FSC-3300-150, Model number: Fuse Colo 150, Serial numbers: F1C0202FUSE1C-150, F1C0203FUSE1C-150, F1C0204FUSE1C-150, F1C0205FUSE1C-150, F1C0206FUSE1C-150, F1C0207FUSE1C-150, F1C0208FUSE1C-150, F1C0209FUSE1C-150, F1C0210FUSE1C-150, F1C0211FUSE1C-150, F1C0212FUSE1C-150, F1C0214FUSE1C-150.