Trolley for Intera/NT MRI System
This recall has been terminated (originally issued July 20, 2004).
- Recall Initiated
- May 13, 2004
- Posted
- July 20, 2004
- Terminated
- April 8, 2005
- Recall Number
- Z-1028-04
- Quantity
- 57 devices
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Patient and MRI tabletop may fall if the tabletop is not positioned correctly on the MRI trolley.
Distribution
Product was distributed to hospitals and medical centers nationwide.
Lot / Code Info
The firm uses site numbers instead of serial numbers: Site Numbers: 105313, 104340, 105929, 84700, 103811, 103904, 504899, 102157, 103592, 85500, 87355, 86404, 103247, 87604, 505682, X1595, 101595, 87062, 103215, 86012, 103620, 101070, 104897, 105486, 83306, 86184, 100826, 84899, 100629, 87527, 84820, 100786, 86085, X1649, 504412, 504741, 87365, 102786, 104886, 103688, 86570, 102095, 103665, 100459, 103611, 102353, 104102, 100462, 103101, 103540, 85158, 103450, 102671, 102896, 102698, 83080, 103782.
Root Cause
Other
Action Taken
The firm sent a letter via certified mail to all customers on May 13, 2004 instructing their customers to check the position of the tabletop to ensure it is correctly aligned on the trolley. The firm is implementing a design modification beginning May 13, 2004. A field service engineer will contact the customers to arrange for installation of the retrofit for the trolley.