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Recall Observatory FDA recall evidence

Device product

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

Z-0282-2014

September 30, 2013

Class II

Product summary

Firm
Draeger Medical, Inc.
Event
Event 66537
Status
Terminated
Classification
Class II
Quantity
139
Official record key
device-enforcement:Z-0282-2014

Official wording

Reason: 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).

Code information: Catalog numbers:MZ00614, MZ01038, MZ02190, MZ02254, and MZ02332

Distribution pattern: 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).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).