FDA-Device2013-11-20Class II

Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care

Draeger Medical, Inc.
Hazard

Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive screw in the motor unit broke and the lift arm fell down approximately 60 cm (23.6 inches).

Sold states
Worldwide distribution: US (Nationwide)and in the country of Canada. (note: the ceiling supply units are not classified as a medical device by Health Canada).
Affected count
139
Manufactured in
3135 Quarry Rd, Telford, PA, United States
Products
Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0282-2014

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