Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
Reported: April 20, 2016 Initiated: January 8, 2016 #Z-1363-2016
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.
Details
- Recalling Firm
- Natus Medical Incorporated
- Units Affected
- 75 units (65 units in the US and 10 units in Pakistan) updated in final status report 36 customers with 96 units.
- Distribution
- Distribution US nationwide and Pakistan.
- Location
- Seattle, WA
Frequently Asked Questions
What product was recalled? ▼
Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.. Recalled by Natus Medical Incorporated. Units affected: 75 units (65 units in the US and 10 units in Pakistan) updated in final status report 36 customers with 96 units..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2016. Severity: Moderate. Recall number: Z-1363-2016.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11