Device product
Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
Z-2823-2020
Product summary
- Event
- Event 85919
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 130612
- Official record key
device-enforcement:Z-2823-2020
Official wording
Reason: LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
Code information: All serial numbers
Distribution pattern: Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, SC, NY, CA, NC, TX, IL, PA, AZ, LA, IN, MA, MO, AR, WI, HI, OR, OH, NJ, TN, NE, WA, KS, MI, MD, WV, KY, UT, MN, IA, GA, AL, DE, AK, VA, OK, NM, CT, SD, NV, ID, MT, ME, VT, MS, WY, NH, MP, DC, ND, GU, PR, AS, RI and the countries of TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, BH.
Derived failure modes
-
Unknown
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.