Z-0168-2015 Class II Terminated
FDA device recall Z-0168-2015 was initiated by Iba Dosimetry Gmbh on September 25, 2014 and is designated Class II. Reason for recall: Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment de… The recall status is terminated (terminated January 26, 2015). Affected quantity: 124 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 12, 2014
- Initiation Date
- September 25, 2014
- Termination Date
- January 26, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 124 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution-Distributed in the US including Guam and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, Mexico, Brazil, Venezuela, Columbia, Panama, China, Japan Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, and Malaysia.