Z-0794-2011

Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit. Consists of diagnostic...

Name: Z-0794-2011 Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit. Consists of diagnostic...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2009-05-12
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-05-12 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit. Consists of diagnostic devices that produce cross sectional images... on 2009-05-12. The reason FDA records is "The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0794-2011
Status: Terminated
Initiated: 2009-05-12
Posted: 2010-12-21
Terminated: 2010-12-28
Recalling firm: Philips North America LLC
Product: Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit. Consists of diagnostic devices that produce cross sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 05/12/2009, Philips began sending out the URGENT-Field Safety Notice MR Accessory Cart to their consignees. The letter identified the affected product and stated that the drawer rails were made from magnetic material and were not according specification. The hazards involved were also provided along with how to identify the affected product. The firm issued the FCO 78100296 and the firm's Field Service Engineer replaced the magnetic rails with the non-magnetic rails at the consignee's site. The consignees can contact contact the Philips Healthcare Call Center at 800-722-9377 #5 (then follow prompts) and reference FCO 78100296 with any communication.
Quantity in commerce: 3 units
Distribution: Nationwide Distribution -- IL, MI, and MD.
Product codes and lots: Site numbers: 505048, 505705, and 41445594.

Product code LNH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)