Z-1363-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 20, 2016
- Initiation Date
- January 8, 2016
- Termination Date
- February 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 units (65 units in the US and 10 units in Pakistan) updated in final status report 36 customers with 96 units.
Product Description
Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
Reason for Recall
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.
Distribution Pattern
Distribution US nationwide and Pakistan.
Code Information
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.