Class 2 Device Recall Stealth(TM) Chamber

• Date Initiated by Firm: April 26, 2017
• Create Date: June 02, 2017
• Recall Status: Terminated on June 11, 2018
• Recall Number: Z-2220-2017
• Recall Event ID: 77301
• 510(K)Number: K945321
• Product Classification: Accelerator, linear, medical - Product Code IYE
• 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
• 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
• Recalling Firm/ Manufacturer: Iba Dosimetry; 3150 Stage Port Drive; Suite 110; Bartlett TN 38133
• For Additional Information Contact: Leah Easley; 901-268-6430
• Manufacturer 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.
• FDA Determined Cause: Device Design
• 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 Service@.iba-group .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 APAC@.iba-group .com Phone: +86 10 8080 9107 Fax: + 86 10 80809298 All other countries: IBA Dosimetry GmbH, Service Dept. Schwarzenbruck , Germany service@.iba-group .com Phone: +49 9128 607-38 Fax: +49 9128 607-26
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE