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REVOLVE SYSTEM (2017-09-07)
- Starting date:
- September 7, 2017
- Posting date:
- September 26, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-64598
Affected products
REVOLVE SYSTEM
Reason
This field action has been initiated due to the inappropriate shipment of four revolve units to a canadian hospital. The user manual included with the product contains a change to remove neurosurgery application that's not yet approved by Health Canada.
Affected products
REVOLVE SYSTEM
Lot or serial number
11955
Model or catalog number
RV0002
Companies
- Manufacturer
-
LIFECELL CORPORATION
#1 MILLENNIUM WAY
BRANCHBURG
08876-3876
New Jersey
UNITED STATES