CLASS II Device recall · Reported 14 Jun 2017 · FDA Enforcement Report
Large Stealth Chamber recalled by Iba Dosimetry
Iba Dosimetry is recalling Large Stealth Chamber, distributed nationwide in the US. The recall was initiated on 26 Apr 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2220-2017
- FDA event ID
- 77301
- Recalling firm
- Iba Dosimetry, Bartlett, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Apr 2017
- FDA classified
- 2 Jun 2017
- Reported
- 14 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Other Medical Devices
Timeline
| 26 Apr 2017 | Recall initiated by company | |
| 2 Jun 2017 | Classified by FDA | +37 days |
| 14 Jun 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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 USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Is Large Stealth Chamber recalled?
Yes. Iba Dosimetry recalled Large Stealth Chamber on 26 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-2220-2017.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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