Agency classClass IIOur severity:High FDA (Devices)·Z-0056-2017·Announced 2016-10-19

Natus Medical Recalls Medix NatalCare LX Incubators Due to Wheel Defect

Natus Medical is recalling 104 Medix NatalCare LX Intensive Care Incubators because a defective base weld may cause wheels to bend out of alignment.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device used for neonatal intensive care. While no injuries are reported, the risk of harm from a malfunctioning incubator is significant, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Natus Medical Incorporated is recalling 104 units of the Medix NatalCare LX Intensive Care Incubator. The affected item numbers are DMNCLX1, KITNC-STLX0003, KITNC-STLX0006, and KITNC-STLX0007. The recall covers specific serial codes listed in the agency's structured data.

The recall is due to a defective base where the weld holding the wheel bushing to the tube is inadequate. This defect has resulted in several complaints of wheels bending out of alignment. The devices were distributed in the United States to the states of AL, CA, FL, IL, IN, KY, LA, MA, MS, NJ, NY, OK, PA, SC, and VA, as well as internationally to Pakistan.

Hospitals and healthcare facilities should stop using the affected incubators and contact Natus Medical Incorporated for instructions on repair or replacement. The FDA has classified this as a Class II recall.

The recalled product

Product: The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.
Manufacturer: Natus Medical Incorporated
Category: Medical Device — Neonatal Incubator
Hazard: structural-defect
equipment-malfunction
Affected units: 104

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

5045
5046
5047
5048
5051
5053
5056
5057
5096
5097
5128
5129
5130
5131
5132
5133
5134
5135
5136
5138

Distribution

Distributed in 15 states:

Same manufacturer · Natus Medical Incorporated

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Same hazard · structural defect