Z-0217-2008
Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403
Skf USA Inc / initiated 2007-07-24 / Terminated / root cause: labeling and UDI
Skf USA Inc began a recall of Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403 on . The reason FDA records is "Sudden failure of the actuator during lifting operation". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0217-2008
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Skf USA Inc
- Product
- Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403
- Reason for recall
- Sudden failure of the actuator during lifting operation
- Root cause tag
- labeling and UDI
- FDA root cause
- Labeling design
- Action
- On or about 7/24/07, the firm sent an Important Safety Information letter and instructions to all known OEMs who purchase and sell SKF actuators for use in patient lifts. The letter reiterated and emphasized the importance of proper handling and maintenance for the actuator. The firm enclosed with this correspondence a proposed letter that the OEMs were asked to send to their customers, including the safety instructions and a new warning label. The firm also is making available for OEMs, dealers and their customers new warning labels to place on all actuators in service. The root cause of the problem is still under investigation by the recalling firm and additional instruction may follow later
- Quantity in commerce
- 1,298 units (Z-0215-0217-2008)
- Distribution
- Worldwide Distribution-USA and Canada
- Product codes and lots
- Serial number 3072047
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