Iba Dosimetry Recalls Large Stealth Chamber Dosimeters for Measurement Deviations
Iba Dosimetry is recalling 110 Large Stealth Chambers because they may show measurement deviations and geometric shadowing when used as reference detectors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is a measurement deviation rather than a direct physical injury, fitting the criteria for a moderate severity recall.
Plain-English summary
Iba Dosimetry is recalling 110 units of the Large Stealth Chamber, including catalog numbers DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, and DS50-103-XL-T. The recall covers specific serial numbers listed in the agency's structured product information.
The recall was initiated because the device may exhibit deviation in measured Percent Depth Doses (PDDs) at shallow depths and geometric shadowing of measured profiles when used as a reference detector in relative dosimetry. This issue affects the accuracy of the dosimetry measurements.
The affected units were distributed worldwide, including the United States and numerous international locations such as Argentina, Australia, Austria, Canada, and the United Kingdom. Users of these devices should contact Iba Dosimetry for instructions on how to proceed with the recall.
The recalled product
- 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
- Manufacturer
- Iba Dosimetry
- Hazard
- Affected units
- 110
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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