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Medical Device Recalls
Class 1 Recall
Welch Allyn PIC 50
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Date Recall
Initiated |
June 30, 2006
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| Date Posted |
July 08, 2006
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| Recall Number |
Z-1195-06
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| 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 Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089
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| Code Information |
Part numbers 971081, 971082, 971083 and 971084; serial numbers 80104, 80119, 80120, 80204, 80211, 80212, 80429, 80432, 80569, 80627, 80661, 80685, 80880, 80964, 81056, 81134, 81263, 81293/81295, 81303, 81445/ 81448, 81733, 81738, 81739, 81744/81752, 81757, 81761/81781, 81802/81807, 81824, 81825, 81835, 81845, 81846, 81852, 81864, 81865, 81868, 81869, 81884/81886, 81892/81897, 81918/81955, 81957, 81983/81990, 81996/82025, 82027/82033, 82035/82039, 82043, 82044, 82061/82080, 82084, 82097/82111, 82122/82128, 82133, 82136/82143, 82150/82169, 82172/82204, 82245, 82252/82273, 82283/82286, 82307/82330, 82340/82349, 82405/82426, 82430, 82460/82490, 82498/82553, 82555/82565, 82568/82570, 82612/82631, 82654/82673, 82689, 82690, 82773/82813, 82827/82830, 82852, 82856/82859, 82906, 82936, 82937, 82958/82977, 82983/83013, 83060/83071, 83083/83090, 83093, 83142/83147, 83153/83172, 83198/83239, 83255, 83368/83370, 83400/83407, 83414/83418, 83420/83429, 83440/83443, 83499/83517, 83578/83580, 83633, 83644, 83645, 83654, 85001/85005, 85009/85013, 85026/85029, 85032/85052, 85073/85079, 85093, 85094, 85110, 85111, 85143/85157, 85187/85201, 85223, 85224, 85226/85238, 85244/85249, 85329, 85332/85334, 85337/85350, 85364, 85365, 85368/85370, 85381, 85388/85398, 85402/85404, 85410/85414, 85420/85433, 85441, 85505/85515, 85517/85520, 85522/85530, 85534, 85552, 85554/85557, 85587/85589, 85602/85607, 85619/85623, 85630, 85645/85655, 85658/85667, 85686, 85728/85734, 85755/85757, 85761/85766, 85771/85785, 85787/85793, 85810, 85812/85823, 85825/85838, 85856/85872, 85877/85884, 85888/85902, 85931/85933, 85945, 85955, 85964, 85967/85970, 86017, 86018, 86024/86029, 86055/86057, 86103, 86104, 86118, 86141/86147, 86149, 86150, 86222/86228, 86230, 86245, 86256/86258, 86261/86268, 86281/86283, 86289/86293, 86295, 86296, 86299, 86305, 86306, 86314, 86315, 86320/86322, 86324/86328, 86334, 86335, 86358, 86359, 86385, 86387, 86389/86399, 86400, 86411, 86412, 86419, 86420, 86439, 86440
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Recalling Firm/
Manufacturer |
MRL, Inc., A Welch Allyn Company
1000 Asbury Dr Ste 17
Buffalo Grove
, Illinois
60089-4551
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| For Addition Information Contact |
Jamie Arnold
315-685-4599
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Reason For
Recall |
The Welch Allyn PIC 50 Defibrillators may display a 'Defib Comm' or 'Pace Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
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| Action |
MRL sent Urgent Medical Device Recall letters dated 6/30/06 via certified mail to the direct accounts informing them of an intermittent connection between a pin and socket on a circuit board inside of the device that could result in a malfunction that prevents or unacceptably delays 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 requested to inspect their PIC 50 units for the affected serial numbers and return the identified units for servicing. The accounts were also instructed to respond to the notification within 5 working days if the unit has displayed the Defib Comm error, and within 30 days if it has not displayed the Defib Comm error by fax or mail. A loaner PIC 50 will then be sent to the consignee with instructions on how to return their unit for correction.
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| Quantity in Commerce |
673 units - USA, 511 units - International
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| Distribution |
Worldwide-including USA, Puerto Rico, Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Malaysia, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sultanate of Oman, Switzerland, United Arab Emirates, United Kingdom and Vietnam.
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