Z-1229-03

Gyroscan Intera 1.0T & 1.5T

Name: Z-1229-03 Gyroscan Intera 1.0T & 1.5T
Creator: Philips Medical Systems
Published: 2002-11-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2002-11-21 / Terminated

FDA source

Philips Medical Systems began a recall of Gyroscan Intera 1.0T & 1.5T on 2002-11-21. The reason FDA records is "Patient burns from cables near or in contact with the patient during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1229-03
Status: Terminated
Initiated: 2002-11-21
Posted: 2003-09-12
Terminated: 2005-01-13
Recalling firm: Philips North America LLC
Product: Gyroscan Intera 1.0T & 1.5T
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Patient burns from cables near or in contact with the patient during use
FDA root cause: Other
Action: On 11/21/02, the firm provided Field Change Order (FCO) 781 00006 to their field employees. This FCO instructed the field employees to visit the consignees and provide them with the addendums to the Instruction For Use Manual.
Distribution: The firm distributed units to hospitals and medical centers throughout the U.S.
Product codes and lots: Serial numbers listed under Gyroscan ACS-NT with software versions R6x, R7x, R8x

Product code LNH

K932645Class IIPhilips Gyroscan Tn 15Philips Medical Systems, Inc. / cleared 1993-12-13

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)