Home / Recalls / Iba Dosimetry / Z-2220-2017

Z-2220-2017 Class II Terminated

Recalled by Iba Dosimetry — Bartlett, TN

FDA device recall Z-2220-2017 was initiated by Iba Dosimetry on April 26, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated June 11, 2018). Affected quantity: 110 units.

Recall Details

Product Type
Devices
Report Date
June 14, 2017
Initiation Date
April 26, 2017
Termination Date
June 11, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
110 units

Product Description

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

Reason for Recall

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.

Distribution Pattern

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, South Africa, South Korea, Spain, Sweden, Taiwan, R.O.C., and United Kingdom.

Code Information

DS50-001-XL-T, Serial Numbers: 24887, 25084, 25085 DS50-002-XL-T, Serial Numbers: 24185, 25219, 25470, 24073, 24187, 24480, 24888, 25089, 24889, 24184, 24813, 24814, 24866, 24867, 24890, 25088, 25220, 24482, 24186, 25090, 24626, 24074, 24189, 25218, 25468, 25469 DS50-003-XL-T, Serial Numbers: 24437, 24260, 24639, 25472, 24257, 24291, 24630, 24640, 24868, 25093, 25478, 24180, 24182, 24259, 24323, 24439, 25222, 24179, 24290, 24293, 24633, 24637, 25091, 25223, 24627, 24077, 24634, 24438, 25476, 25221, 24292, 24263, 24322, 24435, 24628, 24642, 25094, 25479, 24177, 24178, 24641, 25481, 24261, 24076, 24871, 25224, 24078, 24079, 24080, 24175, 24176, 24183, 24256, 24258, 24262, 24264, 24265, 24289, 24321, 24436, 24629, 24631, 24635, 24636, 24638, 24869, 24891, 24892, 24893, 24894, 24896, 24897, 25092, 25095, 25225, 25477 DS50-102-XL-T, Serial Numbers: 24190, 24481, 25467 DS50-103-XL-T, Serial Numbers: 24870, 24898

Other recalls by Iba Dosimetry

  • Z-1703-2025 Class II — myQA iON; Article Number: MQ10-000; (April 1, 2025)
  • Z-0683-2016 Class II — IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2 (December 10, 2015)
  • Z-1212-2015 Class II — COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, rad (February 2, 2015)
  • Z-0168-2015 Class II — COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear acc (September 25, 2014)
  • Z-0456-2014 Class II — iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) (August 20, 2013)

FDA data resources