Device Recall Panorama HFO

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA