Recall Z-1156-2021 ยท JQW Station, Pipetting And Diluting, For Clinical Use
Hamilton Co
HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400
| Date | Jan 15, 2021 |
| Status | Open, Classified |
| Reason | There is a risk that the device can start a fire if flammable liquids contact and enter the device. |
| Root cause | Device Design |
| Action | An URGENT: MEDICAL DEVICE CORRECTION notifications was sent to the consignees via email of 01/15/2021. Hamilton Heater Shaker upgrades were started on 15-JAN- 2021. A device upgrade has been developed to mitigate the risk of the device catching fire. The upgrade consists of a plastic tray within the body of the Hamilton Heater Shaker and a redesigned base plate. These upgrades prevent liquid from reaching the electrical components of the device. The recall notification states: " Hamilton Company Field Service will contact your organization to schedule a time to upgrade your Hamilton Heater |
| Quantity | 4729 units |
| Distribution | US - AL, AR, AZ, CA, CO, CT, DC. DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA. MD, ME. MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI AND WY OUS - AUSTRALIA, AUSTRIA, BRAZIL , CANADA , CHILE, CHINA, , COLOMBIA , FINLAND , GERMANY , ITALY , JA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.