Events

Recall of Device Recall Welch Allyn PIC 50

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MRL, Inc., A Welch Allyn Company.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35688
  • Event Risk Class
    Class 1
  • Event Number
    Z-1195-06
  • Event Initiated Date
    2006-06-30
  • Event Date Posted
    2006-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46623
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Defibrillator - Product Code MJK
  • Reason
    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.
  • 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.

Device

Device Recall Welch Allyn PIC 50
  • Model / Serial
    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
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    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
  • Manufacturer
    MRL, Inc., A Welch Allyn Company

Manufacturer

MRL, Inc., A Welch Allyn Company
  • Manufacturer Address
    MRL, Inc., A Welch Allyn Company, 1000 Asbury Dr Ste 17, Buffalo Grove IL 60089-4551
  • Source
    USFDA