Trolley for Intera/NT MRI System
FDA device recall Z-1028-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Reason for recall
- Patient and MRI tabletop may fall if the tabletop is not positioned correctly on the MRI trolley.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 57 devices
- Distribution
- Product was distributed to hospitals and medical centers nationwide.
- Date initiated
- 2004-05-13
- Date posted
- 2004-07-20
- Date terminated
- 2005-04-08
- Location
- Bothell, WA
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