FDAClass IINovember 20, 2013

Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is recall

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

Why was Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is recalled?

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).

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
Recalling firm
Draeger Medical, Inc.
Quantity
139
Distribution
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).
Recall date
November 20, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls