Recall Z-2220-2017 ยท IYE Accelerator, Linear, Medical
Iba Dosimetry
Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
| Date | Apr 26, 2017 |
| Status | Terminated |
| Reason | When the Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the measured PDDs at shallow depths and geometric shadowing of measured profiles may appear. |
| Root cause | Device Design |
| Action | IBA Dosimetry sent an Field Safety Notice dated April 21, 2017. The letter informed the consignee of the issue and provided the following instruction: If a Stealth Chamber was used during commissioning of Linear Accelerator and Treatment Planning System, the consignee was asked to consider referenced deviations for larger field sizes (>20 x 20 cm) and higher energies (>60MV). They were also instructed to recheck the influence of the PDD deviation and insufficient clearance for 40 x 40 profile on their beam model and its clinical relevancy. For further questions please call (901) 268-6430. |
| Quantity | 110 units |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of : Argentina, Australia, Austria, Canada, Cyprus, France, Germany, Hong Kong, Ireland, Islamic Republic of, Israel, Italy, Japan, Kingdom of Saudi Arabia, Kuwait, New Zealand, People's Republic of China, Philippines, Russia, Slovakia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945321 | WELLHOFER WP700 V. 3.2 Medical Physics Instrumentation, Inc., Jul 12, 1995 |