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U.S. Department of Health and Human Services

Class 2 Device Recall PCR Eleva

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 Class 2 Recall
PCR Eleva
see related information
Date Posted February 04, 2011
Recall Status1 Terminated on August 25, 2011
Recall Number Z-1019-2011
Recall Event ID 57558
Premarket Notification
510(K) Number
K964124 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Philips Electronics... www.medical.philips.com... Philips Medical Systems Nederland B.V". Provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images.
Code Information Site Numbers: 540174, 540902, 543457, 544694, 547848, 547849, 549554, 559966, 42047944, 42047945, 42047946, 42636410, 42636411, 42636457, 42785029, 44620447, 44620448, 44621161, 44892290, 45168464, 45311836, 506103, 44621154, 44621155, 541714, 538773, 539440, 541324, 541389, 541390, 541391, 541392, 541393, 544526, 545356, 42132637, 42132835, 42132836, 42132837, 42132841, 42799764, 42799768, 42799772, 42799784, 42799787, 42799822, 44038390, 44038393, 532267, 532268, 532269, 537619, 537627, 537633, 537650, 538445, 538505, 538506, 538507, 538508, 538701, 538702, 538979, 538980, 539061, 539430, 539431, 539432, 539433, 539434, 539436, 539437, 539438, 539439, 539441, 539442, 539443, 539449, 539450, 539451, 539452, 539453, 539619, 539664, 539740, 539741, 540294, 540352, 540357, 540358, 540359, 540360, 540369, 540428, 540429, 540430, 540489, 540496, 540637, 540966, 540997, 540998, 541035, 541066, 541240, 541252, 541254, 541255, 541307, 541326, 541346, 541349, 541398, 541399, 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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
There is a risk of selecting the wrong patient, when patient is selected in the patient list and the examination tab pressed with background query are running at the same time.
FDA Determined
Cause 2
DESIGN: Software Design
Action On 1/30/2009, Philips began sending out URGENT-Device Correction PCR Eleva notifications to their consignees. The consignees were informed of the hazards as when a patient is selected in patient list and examination tab pressed with background query running at the same time, there would be a risk that the wrong patient is selected. The firm issued the Field Corrective Order (FCO) 73200029 to their representative to correct the problem. The corrective action would be a software upgrade that resolve the issue. All consignees can contact Philips Call Center at 800-722-9377, #5, #2 and reference "FCO 73200029" with any questions.
Quantity in Commerce 686 units
Distribution Nationwide Distribution -- USA, including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WI, WV, and WY and to LANDSTUHL ARMY BASE, APO in United Arab Emirates.
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 = LLZ and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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