510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0282-2014Class II

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

Draeger, Inc. / initiated 2013-09-30 / Terminated / root cause: manufacturing process

Draeger Medical, Inc. began a recall of Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care on . FDA classified it as Class II and gives the reason as "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)". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0282-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Draeger, Inc.
Product
Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
Product code
FQO Table, Operating-Room, Ac-Powered
Reason for recall
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).
Root cause tag
manufacturing process
FDA root cause
Equipment maintenance
Action
An "Urgent Medical Device Recall" notification letter was sent to users in September 2013. The issue was described and recommended actions were provided. Customers may contact (800) 543-5047 and select 1, then 2.
Quantity in commerce
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).
Product codes and lots
Catalog numbers:MZ00614, MZ01038, MZ02190, MZ02254, and MZ02332

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0282-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0282-2014Class IITerminatedVoluntary: Firm initiated