Recall Z-1458-2011 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems North America Co. Phillips
The Panorama HFO system has the Traceable Item Identification (12NC): 9896 030 17741-SW R 2.5.1 (shipped as R 2.5.1, upgraded to R 2.5.3 via FCO). 9896 030 19641-SW R 2.5.3 9896 030 19861-SW R 2.6.1 9896 030 19862-SW R 2.6.1 9896 030 19863-SW R 2.6.3
| Date | Mar 1, 2011 (initiated Feb 5, 2010) |
| Status | Terminated |
| Reason | In the ExamCard MobiFlex the Patient Position is "Prone" which must be "Supine". The result is mislabeling of left and right side of the patient. If this is not detected by the operator there is a risk of wrong treatment or the need of additional X-RAY during treatment. |
| Root cause | Other |
| Action | Philips began sendng out the URGENT-Device Correction Notice letter dated February 5, 2010, ro all affected consignees on February 10, 2010. The consignees were advised to change the patient position from "Prone" immediately to "Supine" and store the corrected ExamCard in the hospital database if they use the ExamCard, MobiFlex dual Injection. Consignees were instructed to call Philips Healthcare Call Center at 800-722-9377 #5 (then follow prompts) and also reference "FCO 78100318" with any communication. |
| Quantity | 82 units |
| Distribution | Nationwide Distribution including the following states: AL, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OR, SC, TN, TX, VA, VT, WI, and WV.AL, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OR, SC, TN, TX, VA, VT, WI, and WV. There was n |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041602 | PANORAMA 1.0T Philips Medical Systems North America, Inc., Jul 26, 2004 |