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U.S. Department of Health and Human Services

Class 2 Device Recall Panorama HFO

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 Class 2 Recall
Panorama HFO
see related information
Date Posted March 01, 2011
Recall Status1 Terminated on August 10, 2011
Recall Number Z-1458-2011
Recall Event ID 57561
Premarket Notification
510(K) Number
K041602 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product 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
Code Information Site Numbers: 533860, 533900, 535230, 535664, 538574, 539374, 540482, 541065, 541851, 542236, 544039, 544148, 544696, 545034, 545732, 545981, 546206, 547843, 547897, 548040, 548064, 549389, 549909, 550324, 550439, 551025, 551583, 552453, 552526, 552609, 553116, 554715, 556146, 556161, 556895, 557599, 41443708, 41444456, 41444458, 41444745, 41445015, 41445018, 41445530, 41445594, 41445595, 41446119, 41455905, 41455908, 41455913, 41455915, 41455923, 41455938, 41455940, 41455954, 42047935, 42057444, 42293607, 42392891, 42608348, 42850814, 42892497, 42917294, 43708886, 44062048, 44247559, 44605983, 45130117, 45245963, 45246494, 45246504, 45445404, 47157157, 47230785, 47455618, 47480028, 47848863, 49060365, 49060404, 49416204, 49424702, 49776644, and 49861074.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Philips Call Center
800-722-9377
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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 in Commerce 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 no foreign consignees.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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