FDA Recall
Terminated
Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray System.
Recall: Z-0166-2010
·
Initiated July 1, 2009
Recall
- Recall Number
- Z-0166-2010
- Event Number
- 53353
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- IZI
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- July 1, 2009
- Posted
- November 10, 2009
- Terminated
- January 12, 2010
- Address
- 51 Valley Stream Pkwy, Malvern, PA, 19355
Description
Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray System.
Reason
The table swivel locking mechanism may not completely engage adn could result in uncontrolled patient movement during transfer resulting in a patient fall.
Action
The recalling firm issued a Customer Safety Advisory Notice dated July 1, 2009 to affected customers via Update Instructions AX025/09/S to inform customer of the potential issues and provide instructions to prevent occurrence. The firm also provided an addendum to User Manual. Direct questions about the recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.
Distribution
Nationwide Distribution.
Quantity
107 units