Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit. Consists of diagnostic devices that
FDA device recall Z-0794-2011 · posted 2010-12-21 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 3 units
- Distribution
- Nationwide Distribution -- IL, MI, and MD.
- Date initiated
- 2009-05-12
- Date posted
- 2010-12-21
- Date terminated
- 2010-12-28
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PANORAMA 1.0T (K041602) | Philips Medical Systems North America, Inc. | 2004-07-26 |
| INTERA-SENSATION FAMILY (K031815) | Philips Medical Systems | 2003-09-10 |