Z-1212-2015 Class II Terminated
FDA device recall Z-1212-2015 was initiated by Iba Dosimetry Gmbh on February 2, 2015 and is designated Class II. Reason for recall: Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during… The recall status is terminated (terminated August 18, 2015). Affected quantity: 124 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2015
- Initiation Date
- February 2, 2015
- Termination Date
- August 18, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 124 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Distribution to the states of AZ and OK., and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, North and South America, Mexico, Brazil, Venezuela, Colombia, Panama, Asia, China, Japan, Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, Malaysia and Guam.