—#95927

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.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031815, K041602
Affected lot / code info: Site numbers: 505048, 505705, and 41445594.

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Nationwide Distribution -- IL, MI, and MD.

Timeline

Recall initiated: 2009-05-12
Posted by FDA: 2010-12-21
Terminated: 2010-12-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95927. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.