BEUDAMED
    FDA Enforcement Class II Terminated

    Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.

    Recall: Z-1363-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1363-2016
    Event ID
    72894
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Natus Medical Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2016
    Initiation Date
    January 8, 2016
    Classification Date
    April 11, 2016
    Termination Date
    February 10, 2017
    Address
    5900 1st Ave S, N/A, Seattle, WA, 98108-3248, United States

    Description

    Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.

    Reason

    NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose and possibly result in the port detaching from the incubator.

    Code Info

    Serial numbers: 5337; 5336; 5335; 5334; 5333; 5332; 5331; 5330; 5329; 5328; 5327; 5326; 5325; 5324; 5323; 5294; 5293; 5292; 5291; 5290; 5289; 5287; 5283; 5282; 5281; 5280; 5278; 5277; 5276; 5257; 5256; 5255; 5254; 5253; 5252; 5251; 5250; 5249; 5248; 5228; 5227; 5226; 5225; 5224; 5223; 5222; 5221; 5220; 5219; 5214; 5213; 5212; 5211; 5210; 5209; 5139; 5138; 5136; 5135; 5134; 5133; 5132; 5131; 5130; 5129; 5097; 5096; 5057; 5056; 5053; 5051; 5048; 5047; 5046; 5045. Serial numbers were updated in the final status report. They are as follows: 5552; 5551; 5550; 5549; 5510; 5509; 5508;5507; 5506; 5505; 5504; 5389; 5388; 5385; 5383; 5337; 5336; 5335; 5334; 5333; 5332; 5331; 5330; 5329; 5328; 5327; 5326; 5325; 5324; 5323; 5322; 5294; 5293; 5292; 5291; 5290; 5289; 5288; 5287; 5286; 5285; 5284; 5283; 5282; 5281; 5280; 5279; 5278; 5277; 5276; 5257; 5256; 5255; 5254; 5253; 5252; 5251; 5250; 5249; 5248; 5228; 5227; 5226; 5225; 5224; 5223; 5222; 5221; 5220; 5219; 5214; 5213; 5212; 5211; 5210; 5209; 5139; 5138; 5136; 5135; 5134; 5133; 5132; 5131; 5130; and 5129. The following serial numbers were removed: 5097; 5096; 5057; 5056; 5053; 5051; 5048; 5047; 5046; and 5045.

    Distribution

    Distribution US nationwide and Pakistan.

    Quantity

    75 units (65 units in the US and 10 units in Pakistan) updated in final status report 36 customers with 96 units.