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U.S. Department of Health and Human Services

Class 2 Device Recall Auto sampler

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 Class 2 Device Recall Auto samplersee related information
Date Initiated by FirmOctober 09, 2024
Date PostedNovember 26, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0553-2025
Recall Event ID 95632
Product Classification Apparatus, high pressure liquid chromatography - Product Code KIE
ProductAutosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
Code Information Model/UDI-DI/Serial Number: SIL-20ACXR CL/04540217420131/L20995250001, L20995250002, L20995250003, L20995250004, L20995250005, L20995250006, L20995250007, L20995250008, L20995350010, L20995350011, L20995350012, L20995350013, L20995350014, L20995350015, L20995450016, L20995450017, L20995450018, L20995450019, L20995450020, L20995450021, L20995450022, L20995450023, L20995450024, L20995450025, L20995450026, L20995550027, L20995550028, L20995550029, L20995550030, L20995650031, L20995650032, L20995650033, L20995650034, L20995650035, L20995650036, L20995650037, L20995650038, L20995650039, L20995650040, L20995650041, L20995650042, L20995650043, L20995650044, L20995650045, L20995650046, L20995560001, L20995660002, L20995660003, L20995660004, L20995660005, L20995660006, L20995660007, L20995660008, L20995660009, L20995660010, L20995660011, L20995660012, L20995660013, L20995660014, L20995660015, L20995660016, L20995660017, L20995660018, L20995660019, L20995660020, L20995660021, L20995660022, L20995660023, L20995660024, L20995660025, L20995660026, L20995660027, L20995660028, L20995660029, L20995660030, L20995660031, L20995660032, L20995660033, L20995660034, L20995660035, L20995660036, L20995660037, L20995660038, L20995660039, L20995660040, L20995660041, L20995660042, L20995660043, L20995660044, L20995660045, L20995660046, L20995660047, L20995660048, L20995660049, L20995660050, L20995660051, L20995660052, L20995660053, L20995660054, L20995660055, L20995660056, L20995660057, L20995250009, L20995270001, L20995270002, L20995270003, L20995270004, L20995270005, L20995370006, L20995370007, L20995370008, L20995370009, L20995370010, L20995370011, L20995370012, L20995370013, L20995370014, L20995370015, L20995370016, L20995370017, L20995370018, L20995370019, L20995370020, L20995370021, L20995370022, L20995370023, L20995370024, L20995370025, L20995470028, L20995770032. SIL-20ACHT CL/04540217420124/L20985350001, L20985450002, L20985750003, L20985750004. SIL-30AC CL/04540217420155/L21005250001, L21005250002, L21005250003, L21005250004, L21005250005, L21005250006, L21005250007, L21005350008, L21005350009, L21005350010, L21005350011, L21005350012, L21005350013, L21005350014, L21005350015, L21005350016, L21005350017, L21005350018, L21005350019, L21005350020, L21005350021, L21005350022, L21005350023, L21005350024, L21005450025, L21005550026, L21005550027, L21005650028, L21005650029, L21005750030, L21005750031, L21005570001, L21005570002, L21005670003, L21005670004, L21005670005, L21005670006, L21005670007, L21005670008, L21005770009, L21005770010, L21005770011, L21005770012, L21005770013, L21005770014.
FEI Number 3010607747
Recalling Firm/
Manufacturer		 Shimadzu Corp. Analytical & Measuring Instruments Div.
1 Chome 1
Nishinokyokuwabara-Cho; Nakagyo; Hon-Machi; Higashiyama
Kyoto Japan
Manufacturer Reason
for Recall		There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.
FDA Determined
Cause 2		Device Design
ActionOn 10/9/24, field safety notices were mailed to customers asking them to do the following: (1) From the front and the right sides, check to see if there is any condensation water leakage. (2) If any condensation water leakage is found in the inspection, install Dew Tray Replace Kit (S228-61501-41). (3) Regardless of the checking result, attach the Main PCB Protective Sponge (S228-69971-41) For questions, please call 800-477-1227 between the hours of 8:30-5:00 EST or visit www.ssi.shimadzu.com.
Quantity in Commerce179
DistributionWorldwide - US Nationwide distribution in the states of MS, AR, TX, CA, MA, MI, FL, OK, WI, IN, MN, OH, NJ, NY, IL, KY, NV, HI, SD, ID, MI, UT, WA, MO, VA, GA and the countries of DE, CN, JP, UY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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