Z-2094-2015 Class II Terminated
FDA device recall Z-2094-2015 was initiated by Breas Medical AB on November 7, 2014 and is designated Class II. Reason for recall: Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be regis… The recall status is terminated (terminated April 7, 2016). Affected quantity: 846 US.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2015
- Initiation Date
- November 7, 2014
- Termination Date
- April 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 846 US
Product Description
Reason for Recall
Distribution Pattern
Worldwide - United States Nationwide Distribution and the countries: Argentina, Belgium, Chile, Cyprus, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Netherlands, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, UAE and United Kingdom.