GE Healthcare · X-ray R&FDefinium
Unit no longer meets the FDA minimum half value layer requirement of 2.9mm aluminum at 80 kVp.
Symptom
Unit no longer meets the FDA minimum half value layer requirement of 2.9mm aluminum at 80 kVp. Replacement of the x-ray tube on a unit manufactured on or after June 10, 2006 will result in the unit no longer meeting the FDA minimum half value layer requirement of 2.9mm aluminum at 80 kVp. The additional filtration added to the x-ray tube port during Manufacturing is not provided with replacement x-ray tubes.
Applies to
- Models
- Definium
- Product
- AMX4 Definium AMX 700 Portables AMX4+
- Component
- Xray Tube Reload D2652P Xray Tube New D2651P (2185226) Filtration Kit 5180389 Part #: 5180389 Part Type: GP CONSUMABLES Part Weight: 0.00 LBR Repairable: No Returnable: No Hazardous Material: N Description: Kit to implement the beam quality requirement for the AMX4 series designated by the FDA in 21 CFR 1020.30 m1 as of 10 June 2006. Consists of aluminum cup filter, HVL label, and installation instructions. FRU: Yes Status: Orderable
- Area
- X-ray R&F
Full cause & step-by-step resolution
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