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U.S. Department of Health and Human Services

Class 2 Device Recall Welch Allyn PIC 50 Portable Monitor/Defibrillator

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  Class 2 Device Recall Welch Allyn PIC 50 Portable Monitor/Defibrillator see related information
Date Initiated by Firm November 15, 2006
Date Posted January 19, 2007
Recall Status1 Terminated 3 on October 31, 2007
Recall Number Z-0343-2007
Recall Event ID 36785
510(K)Number K974034  
Product Classification Defibrillator - Product Code MJK
Product Welch Allyn PIC 50 Portable Intensive Care System, Multi-Parameter Monitor/Defibrillator; a portable 12V internal battery powered defibrillator; Manufactured by MRL Inc., a WelchAllyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089-Part Numbers-971081,971082,971083,971084.
Code Information Part Numbers 971081, 971082, 971083 and 971084; Serial numbers 80052, 80141, 80190, 80191, 80425, 80426, 80430, 80431, 80432, 80435, 80436, 80587, 80826, 80915, 80916, 80918, 80920, 80921, 80923, 80924, 80925, 80926, 80927, 80928, 80929, 80930, 80932, 80934, 80960, 80962, 80963, 80967, 80969, 80971, 80972, 80973, 80974, 80975, 80976, 80981, 80983, 80987, 80989, 80990, 80991, 80992, 80993, 81003, 81004, 81005, 81006, 81007, 81008, 81009, 81010, 81011, 81012, 81013, 81014, 81015, 81016, 81017, 81018, 81019, 81020, 81022, 81023, 81024, 81025, 81026, 81027, 81028, 81029, 81030, 81031, 81032, 81033, 81034, 81035, 81036, 81037, 81038, 81044, 81045, 81046, 81047, 81049, 81070, 81094, 81102, 81103, 81104, 81105, 81109, 81110, 81111, 81112, 81113, 81165, 81167, 81178, 81179, 81181, 81184, 81187, 81188, 81192, 81194, 81197, 81258, 81297, 81499, 81627, 81765, 81767, 81769, 81770, 81773, 81803, 81804, 81823, 81827, 81828, 81829, 81832, 81833, 81834, 81835, 81837, 81838, 81839, 81840, 81841, 81842, 81843, 81844, 81845, 81846, 81853, 81855, 81857, 81858, 81860, 81861, 81862, 81863, 81864, 81865, 81866, 81867, 81868, 81869, 81884, 81885, 81886, 81920, 81921, 81922, 81923, 81924, 81925, 81926, 81927, 81928, 81929, 81930, 81931, 81932, 81933, 81934, 81935, 81936, 81937, 81938, 81939, 81940, 81941, 81942, 81943, 81944, 81945, 81946, 81949, 81957, 81983, 81984, 81985, 81986, 81987, 81988, 81989, 81990, 81996, 81997, 81998, 81999, 82000, 82001, 82003, 82004, 82005, 82016, 82017, 82019, 82021, 82022, 82023, 82024, 82025, 82027, 82028, 82034, 82035, 82036, 82037, 82038, 82039, 82043, 82061, 82062, 82063, 82064, 82065, 82066, 82067, 82068, 82069, 82070, 82071, 82072, 82073, 82074, 82075, 82076, 82077, 82078, 82079, 82080, 82098, 82099, 82100, 82101, 82102, 82103, 82104, 82105, 82106, 82107, 82108, 82109, 82111, 82122, 82123, 82124, 82126, 82127, 82128, 82160, 82161, 82162, 82163, 82164, 82165, 82169, 82172, 82173, 82174, 82175, 82176, 82177, 82178, 82179, 82180, 82181, 82182, 82183, 82184, 82185, 82186, 82192, 82193, 82194, 82195, 82196, 82198, 82199, 82200, 82201, 82202, 82204, 82252, 82253, 82254, 82255, 82256, 82257, 82258, 82259, 82260, 82261, 82262, 82263, 82264, 82265, 82266, 82267, 82268, 82270, 82271, 82272, 82273, 82284, 82285, 82286, 82317, 82318, 82319, 82321, 82322, 82323, 82324, 82325, 82326, 82327, 82328, 82329, 82330, 82342, 82343, 82344, 82346, 82347, 82348, 82349, 82408, 82409, 82411, 82412, 82413, 82414, 82415, 82416, 82417, 82418, 82419, 82421, 82424, 82426, 82430, 82461, 82462, 82463, 82464, 82465, 82466, 82467, 82468, 82469, 82470, 82471, 82472, 82473, 82474, 82475, 82517, 82518, 82519, 82520, 82521, 82522, 82528, 82529, 82530, 82531, 82532, 82533, 82536, 82537, 82538, 82550, 82552, 82553, 82555, 82556, 82557, 82559, 82560, 82561, 82562, 82563, 82564, 82565, 82569, 82570, 82612, 82613, 82614, 82615, 82616, 82617, 82618, 82619, 82621, 82623, 82624, 82625, 82626, 82627, 82628, 82629, 82630, 82631, 82655, 82656, 82657, 82658, 82659, 82660, 82661, 82662, 82663, 82664, 82665, 82666, 82667, 82668, 82669, 82670, 82671, 82672, 82689, 82690, 82773, 82774, 82775, 82776, 82777, 82778, 82779, 82780, 82781, 82782, 82783, 82784, 82785, 82786, 82787, 82788, 82789, 82790, 82791, 82792, 82793, 82794, 82795, 82796, 82797, 82798, 82799, 82800, 82801, 82802, 82803, 82804, 82805, 82806, 82807, 82808, 82809, 82810, 82811, 82812, 82813, 82827, 82828, 82829, 82830, 82852, 82857, 82858, 82859, 82962, 82965, 82966, 82967, 82975, 82986, 82989, 82991, 82998, 83010, 83011, 83012, 83013, 83060, 83061, 83062, 83063, 83064, 83065, 83066, 83067, 83084, 83088, 83089, 83090, 83142, 83144, 83145, 83147
Recalling Firm/
Manufacturer		 MRL, Inc., A Welch Allyn Company
1000 Asbury Dr Ste 17
Buffalo Grove IL 60089-4551
For Additional Information Contact Jamie Arnold
315-685-4599
Manufacturer Reason
for Recall		 Shock Delay:The monitor-defibrillator may display an 'ECG Comm' error message on the display during use, which may prevent or cause an unacceptable delay the delivery of a defibrillation shock. This delay could result in failure to resuscitate the patient.
FDA Determined
Cause 2		 Other
Action MRL sent Urgent Medical Device Recall letters dated 11/8/06 via certified mail on 11/15/06 to the direct accounts informing them of an intermittent connection between the J5 cable and its mating connector on a circuit board inside of the device that could result in a malfunction that could prevent or unacceptably delay the delivery of a defibrillating shock, which possibly could result in failure to resuscitate the patient. The accounts were provided a list of the affected units'' parts/serial numbers and were requested to inspect their PIC 50 units for the affected serial numbers and return the identified units for servicing. Until their PIC 50 is serviced, the accounts were instructed to check the unit before each shift by using the self-test, which is automatically initiated by powering up the device. If the 'ECG Comm' error occurs during use, cycling the power off-on may clear the error. Even if power cycling clears the device, the accounts were instructed to contact Welch Allyn - MRL to obtain priority servicing of the affected unit. The accounts were also instructed to respond to the notification within 30 days by fax or mail, or by calling Welch Allyn - MRL Technical Support at 1-800-462-0777, to schedule their PIC 50 for preventative service. Welch Allyn will provide the accounts with a loaner PIC 50 after receiving the form with instructions to send back the PIC 50 in the same shipping box accompanying the loaner unit. Any questions were directed to Welch Allyn-MRL Technical Support at 1-800-462-0777.
Quantity in Commerce 510 units
Distribution Worldwide-USA, Australia, Belgium, Canada, Egypt, Finland, France, Germany, Ireland, Italy, Jordan, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sultanate of Oman, United Arab Emirates and the United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MJK and Original Applicant = MEDICAL RESEARCH LABORATORIES, INC.
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