Class II — Iba Dosimetry
| Recalling firm | IBA Dosimetry GmbH |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| Product | 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 |
| 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, South Africa, South Korea, Spain, Sweden, Taiwan, R.O.C., and United Kingdom. |
| Initiated | 2017-04-26 |
| Classified | 2017-06-02 |
| Terminated | 2018-06-11 |
| Recall number | Z-2220-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Iba Dosimetry (Z-2220-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77301/
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