Z-1028-04

Trolley for Intera/NT MRI System

Name: Z-1028-04 Trolley for Intera/NT MRI System
Creator: Philips Medical Systems Sales & Service Region No. America
Published: 2004-05-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2004-05-13 / Terminated

FDA source

Philips Medical Systems Sales & Service Region No. America began a recall of Trolley for Intera/NT MRI System on 2004-05-13. The reason FDA records is "Patient and MRI tabletop may fall if the tabletop is not positioned correctly on the MRI trolley". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1028-04
Status: Terminated
Initiated: 2004-05-13
Posted: 2004-07-20
Terminated: 2005-04-08
Recalling firm: Philips North America LLC
Product: Trolley for Intera/NT MRI System
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Patient and MRI tabletop may fall if the tabletop is not positioned correctly on the MRI trolley.
FDA 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 in commerce: 57 devices
Distribution: Product was distributed to hospitals and medical centers nationwide.
Product codes and lots: 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.

Product code LNH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)