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.
This recall has been terminated (originally issued December 21, 2010).
- Recall Initiated
- May 12, 2009
- Posted
- December 21, 2010
- Terminated
- December 28, 2010
- Recall Number
- Z-0794-2011
- Quantity
- 3 units
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system.
Distribution
Nationwide Distribution -- IL, MI, and MD.
Lot / Code Info
Site numbers: 505048, 505705, and 41445594.
Root Cause
Nonconforming Material/Component
Action Taken
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.