| Date Initiated by Firm | January 08, 2016 |
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| Date Posted | April 11, 2016 |
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| Recall Status1 |
Terminated 3 on February 10, 2017 |
| Recall Number | Z-1363-2016 |
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| Recall Event ID |
72894 |
| 510(K)Number | K070291 |
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| Product Classification |
Incubator, neonatal - Product Code FMZ
|
| Product | Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator. |
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| 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. |
Recalling Firm/
Manufacturer |
Natus Medical Incorporated
5900 1st Ave S
Seattle WA 98108-3248
|
| For Additional Information Contact | Technical Services Department
888-496-2887 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Process control |
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| Action | Natus of Seattle, WA began sending the Urgent Field Safety Notice NatalCare LX Incubator letter (DOC-017939A) to consignees on 1/8/16.
A repair kit to correct this issue is now available for repair of affected units. Consignees should complete the NatalCare LX Incubator Oval Port Hinge Repair Kit Order Form and FAX it 847-949-6031 or scan and email this form to Natus_Quality_Programs@natus.com.
Alternately you can telephone Natus Technical Service at 888-496-2887 and order the kit from a specialist.
Natus will send the kit(s) free-of-charge to the address you specify. Each upgrade will require up to - 1 hour of time and require simple hand tools.
If you have any questions, please contact Technical Service at 888-496-2887 or send email to: customer.service@natus.com |
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| Quantity in Commerce | 75 units (65 units in the US and 10 units in Pakistan) updated in final status report 36 customers with 96 units. |
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| Distribution | Distribution US nationwide and Pakistan. |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = FMZ
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