Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
- Recall Initiated
- November 4, 2019
- Recall Number
- Z-0763-2020
- Quantity
- 46
Reason for Recall
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
Distribution
US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, and Puerto Rico.
Lot / Code Info
Serial Numbers: 10110770 11030805 11030806 11070845 11070848 11070849 11110900 12020978 12020982 12030999 12041003 12061014 12061018 12061020 12081040 12091074 12101104 12121186 12121187 13031215 13101263 14021301 14031313 14041321 14051332 14071353 14081359 14091368 14091371 14121400 14121403 15021426 15031440 15041444 15091473 15091478 15101484 15101487 15121505 16011512 16021514 16021517 16021518 16041533 16121595 19011923
Root Cause
Device Design
Action Taken
Urgent Field Safety Notice notification letters dated 10/23/19 were sent to customers. Action to be taken by the customer/user: The user shall take note of amendment/reinforcement of Instructions for Use (IFU) and Service Manual, attached to this FN and, if it is the case, request a service technician to do the periodic preventive maintenance the user shall replace the attached pages in the User Manual and in the Service Manual, prescribing the periodic replacement of the angulation chain. Fill the table present in the addendum; In the cell "Next replacement date" write the date adding 8 years to the replacement date. All the examinations performed on the device before the recall remain valid. The IFU and the Service Manual need to be amended to prescribe the replacement of the angulation chain after 8 years of service life of the unit. This notice needs to be passed to all users of Apollo, Apollo DRF, Apollo EZ and to all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred.