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Terminated

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.

FDA Recall Z-0794-2011 · Posted 2010-12-21

Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeLNH
Date Initiated2009-05-12
Date Terminated2010-12-28
Product Quantity3 units

Reason for Recall

The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution -- IL, MI, and MD.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041602PANORAMA 1.0TPhilips Medical Systems North America, Inc. · 2004-07-26K031815INTERA-SENSATION FAMILYPhilips Medical Systems · 2003-09-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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