Trumpf Medical Systems, Inc. recalls Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical light

Recalled August 19, 2015 · FDA recall Z-2355-2015 · Trumpf Medical Systems

Hazard

Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. · FDA Class II

Units

9,287 units total

Sold at

Worldwide Distribution-US (nationwide) including Puerto Rico, and the countries of Angola, Antilles, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Belgium, Bulgaria, Bahrain, Brasilia, Belarus, Canada, Switzerland, Chile, China, Columbia, Cyprus, Czech Republic, Germany, Denmark, Algerian, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgian Republic, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon, Liechtenstein, Lithuania, Luxembourg, Latvia, Libya, Morocco, Macedonia, Myanmar/Burma, Malta, Mauritius, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Pakistan, Poland, Palestine, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sudan, Sweden, Singapore, Slovenia, Slovakia, San Marino, Syria, Thailand, Turkmenistan, Tunisia, Turkey, Taiwan, Ukraine, United Arabian Emirates, Uruguay, Venezuela, British Virgin Islands, Vietnam, Kosovo, Serbia and South Africa.*

Description

Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.

Product

Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

Manufacturer(s)

Trumpf Medical Systems, Inc.

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