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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-0554-2025
Recall Event ID 95633
Product Classification Apparatus, high pressure liquid chromatography - Product Code KIE
ProductAutosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Code Information Model/UDI-DI/Serial Numbers: SIL-40C XR CL/04540217420582/L2C316051002, L2C316051003, L2C316051004, L2C316051005, L2C316051006, L2C316051007, L2C316151012, L2C316151013, L2C316151014, L2C316151015. SIL-40C X3 CL/04540217420575/L2C305850001, L2C305950002, L2C306151025, L2C306051001, L2C306051002, L2C306051003, L2C306051004, L2C306051005, L2C306051007, L2C306051006, L2C306051008, L2C306051009, L2C306051010, L2C306051011, L2C306051012, L2C306051013, L2C306051014, L2C306051015, L2C306151017, L2C306151018, L2C306151022, L2C306151023, L2C306151024, L2C306151026, L2C306151028, L2C306151027, L2C306151029, L2C306151030, L2C306151031, L2C306151032, L2C306151033, L2C306151034, L2C306151035, L2C306151036, L2C306151037, L2C306151038, L2C306151040, L2C306151039. Firmware versions below 1.16.
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 occurring in the gap between thermal insulation material on the underside of the main base dropping onto the main board The symptoms and errors differ depending on the position where the water drops adhere. To date there have been examples of reports of inter-board communication errors, HOME POSITION error or SLIP error of XYZ drive units. The failure could result in delay of 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: Check the Serial Numbers, and if the instruments are affected by this issue, contact your regional office. The corrective actions to be taken to affective products are (1) Add a cover part to the main board. (2) Update the SIL-40 firmware to Ver. 1.16 or above. For questions, please call 800-477-1227 between the hours of 8:30-5:00 EST or visit www.ssi.shimadzu.com.
Quantity in Commerce48
DistributionWorldwide - US Nationwide distribution in the states of DE, PA and the country of DE.
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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