Recall Z-0033-2014 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems (Cleveland) Inc
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
| Date | Oct 21, 2013 (initiated Aug 7, 2013) |
| Status | Terminated |
| Reason | There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system. |
| Root cause | Device Design |
| Action | Philips Healthcare sent an Urgent Medical Device Correction letter via certified mail on August 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information with all of their staff who need to be aware of the contents of this communication. Philips Healthcare will perform any necessary corrective actions prior to the customer's next cryogen refill. Customers with questions were instructed to contact their Philips field service representative: Technical Support Line 1-800-7 |
| Quantity | Total 511 (Asset 0.5T,: 35 units Apollo 0.5T: 15 units, Infinion 1.5T: 116 units, Eclipse/Polaris 1.5T: 290 units, Panor |
| Distribution | Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003853 | INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 Philips Medical Systems (Cleveland), Inc., Feb 13, 2001 |
| K013858 | INFINION 0.6T MR IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc., Jan 22, 2002 |
| K964626 | EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE Philips Medical Systems (Cleveland), Inc., Feb 10, 1997 |
| K971884 | ASSET APOLLO Philips Medical Systems (Cleveland), Inc., Aug 20, 1997 |