Edge Nuclear Magnetic Resonance Imaging System. "1.5T Edge High-Field Magnetic Resonance Imaging System, Picker Internat
FDA device recall Z-2429-2010 · posted 2010-09-17 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Water may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite.
- Action taken
- Philips issued an Urgent Correction letter dated 09/19/2008 to their consignees, identifying the reason for the recall and the affected products. The firm issued the Field Change Order (FCO) 78100232. Field service engineers will visit each consignee and conduct an inspection of the magnets venting system of Edge, Vista, Eclipse, Polaris, Infinion, and Panorama 0.6T MRI systems. The consignees should contact the Philips Call Center at 1-800-772-9377, #5 #2 and reference "FCO 78100232".
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 28 units
- Distribution
- Nationwide Distribution: USA., including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, RI, S
- Date initiated
- 2008-09-19
- Date posted
- 2010-09-17
- Date terminated
- 2010-09-17
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE (K964626) | Philips Medical Systems (Cleveland), Inc. | 1997-02-10 |
| 1.5T EDGE AND 1.0T VISTA SYSTEMS (K931544) | Philips Medical Systems (Cleveland), Inc. | 1993-11-22 |