Z-2220-2017Class II

Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T...

Name: Z-2220-2017 Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T...
Creator: Iba Dosimetry
Published: 2017-04-26
License: https://open.fda.gov/license/

IBA Dosimetry GmbH / initiated 2017-04-26 / Terminated / root cause: design

FDA source

Iba Dosimetry began a recall of 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 on 2017-04-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2220-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-26
Posted: 2017-06-02
Terminated: 2018-06-11
Recalling firm: IBA Dosimetry GmbH
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
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: design
FDA root 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 [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
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2220-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2220-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02

Product code IYE

K945321Class IIWellhofer Wp700 V. 3.2Medical Physics Instrumentation, Inc. / cleared 1995-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)