Z-0864-2015 Class II Terminated
FDA device recall Z-0864-2015 was initiated by Bausch & Lomb Inc on Nov 4, 2014 and is designated Class II. Reason for recall: A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. The recall status is terminated (terminated Mar 23, 2017). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 31, 2014
- Initiation Date
- Nov 4, 2014
- Termination Date
- Mar 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA Distribution including to the states of AL, CA, CT, FL, GA, HI, IL, IN, KS, MI, MN, MO, MS, NH, NY, OH, OK, PA, TX, WI and WV., and to the countries of Austria, Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Italy, Jordan, Malaysia, Morocco, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, Turkey and the United Arab Emirates.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0864-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026