Trumpf Medical Systems, Inc. recalls Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lights are inte…

Recall date

July 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2356-2015

FDA classification

Class II

Brand / firm

Trumpf Medical Systems, Inc.

Sold / distributed

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, Denmar…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.