Recall Z-1395-2025 ยท LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Remel, Inc
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ
| Date | Mar 19, 2025 (initiated Feb 12, 2025) |
| Status | Open, Classified |
| Reason | Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard. |
| Root cause | Nonconforming Material/Component |
| Action | On February 12, 2025, the firm notified affected customers through Urgent Medical Device Recall letters. Customers were instructed to check the manufacturing label on the back or bottom of their printer to confirm if it was one of the affected printers. If the label lists Zebra Technologies as the manufacturer, please use the validation form on the Zebra website to fully validate if your power supply is affected. More information can be found on the Zebra website: https://www.zebra.com/us/en/power-supply-recall.html |
| Quantity | 41 |
| Distribution | Domestic distribution to AL, AZ, CA, FL, GA, IN, KS, KY, MD, MI, NE, NY, OH, PA, TN, TX, WI. International distribution to Canada and the Bahamas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191918 | Thermo Scientific Sensititre ARIS HiQ System Thermo Fisher Scientific, Nov 6, 2019 |