510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-1458-2011

The Panorama HFO system has the Traceable Item Identification (12NC): 9896 030 17741-SW R 2.5.1 (shipped as R...

Philips North America LLC / initiated 2010-02-05 / Terminated / root cause: labeling and UDI
FDA source (opens on fda.gov)

Philips Medical Systems North America Co. Phillips began a recall of 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... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1458-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
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
Product code
LNH System, Nuclear Magnetic Resonance Imaging
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.
Root cause tag
labeling and UDI
FDA 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 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.
Product codes and lots
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.