Draeger Ceiling Supply Units Recalled Due to Broken Drive Screw
Draeger Medical is recalling 139 Movita 603x/DVE 803x Ceiling Supply Units because a broken drive screw caused the lift arm to fall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a mechanical defect in a medical device used in critical care settings that poses a risk of physical injury (falling object), but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Draeger Medical, Inc. is recalling 139 units of the Draeger Movita 603x/DVE 803x Ceiling Supply Unit. These devices are intended for use in operating theaters and intensive care settings. The affected units are identified by catalog numbers MZ00614, MZ01038, MZ02190, MZ02254, and MZ02332.
The recall was initiated because cases were encountered where the drive screw in the motor unit broke, causing the lift arm to fall down approximately 60 cm (23.6 inches). This mechanical failure presents a risk of injury to patients or staff in the vicinity of the device.
The affected units were distributed nationwide in the United States and in Canada. Note that Health Canada does not classify these ceiling supply units as a medical device. Users should contact Draeger Medical, Inc. for instructions on how to address the defect.
The recalled product
- Product
- Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 139
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Catalog numbers:MZ00614
- MZ01038
- MZ02190
- MZ02254
- and MZ02332
Distribution
Distributed nationwide across the United States.
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