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Terminated

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

FDA Recall Z-2220-2017 · Posted None

Recalling FirmIba Dosimetry
Recall StatusTerminated
Product CodeIYE
Date Initiated2017-04-26
Date Terminated2018-06-11
Product Quantity110 units

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.

Firm 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. Contact information Should you have questions or require additional information, please contact the Customer Service Team at:: South and Middle America, USA, and Canada : IBA Dosimetry America Bartlett, TN, USA US [email protected] .com Phone: +1 901 386-2242 Fax: +1 901 382-9453 Asia Pacific, A Australia and New Zealand: IBA China, Dosimetry Dept. Beijing, China Service [email protected] .com Phone: +86 10 8080 9107 Fax: + 86 10 80809298 All other countries: IBA Dosimetry GmbH, Service Dept. Schwarzenbruck , Germany [email protected] .com Phone: +49 9128 607-38 Fax: +49 9128 607-26

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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