FDA Medical Device Recalls (openFDA)
Philips Medical Systems Sales & Service Region No. America: Trolley for Intera/NT MRI System
- Recall number
- Z-1028-04
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Product
- Trolley for Intera/NT MRI System
- Status
- Terminated
- Initiated
- 2004-05-13
- Posted
- 2004-07-20
- Terminated
- 2005-04-08
- Reason
- Patient and MRI tabletop may fall if the tabletop is not positioned correctly on the MRI trolley.
- Root cause
- Other
- Action
- 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.
- Quantity
- 57 devices
- Distribution
- Product was distributed to hospitals and medical centers nationwide.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28