Bausch & Lomb Inc recalls Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY

Recalled December 31, 2014 · FDA recall Z-0862-2015 · Bausch & Lomb

Hazard

A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. · FDA Class II

Units

106

Sold at

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.

Description

A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.

Product

Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY

Manufacturer(s)

Bausch & Lomb Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →