Z-1201-03

Gyroscan 1.5T Intera

Name: Z-1201-03 Gyroscan 1.5T Intera
Creator: Philips Medical Systems
Published: 2002-05-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2002-05-02 / Terminated

FDA source

Philips Medical Systems began a recall of Gyroscan 1.5T Intera on 2002-05-02. The reason FDA records is "Patient burns related to high SAR levels and the combined use of Synergy Body Coil and synergy Flex-M coil". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1201-03
Status: Terminated
Initiated: 2002-05-02
Posted: 2003-09-12
Terminated: 2005-04-11
Recalling firm: Philips North America LLC
Product: Gyroscan 1.5T Intera
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Patient burns related to high SAR levels and the combined use of Synergy Body Coil and synergy Flex-M coil
FDA root cause: Other
Action: The firm issued a Field Change Order to their field personnel instructing them to add new labeling to the User Manual. 05/02/2002 A letter was issued to customers.
Quantity in commerce: see above
Distribution: The firm distributed units to hospitals and medical centers nationwide.
Product codes and lots: Serial numbers provided above

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)