Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Summary
The FDA issued a Class II for Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL by Shimadzu Corp. Analytical & Measuring Instruments Div.. Reason: 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.
Details
Source
Device Recall
External ID
Z-0554-2025
Action Date
2024-12-04
Status
Ongoing
Category
device
Product Description
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Lot/Code Info: 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.
Quantity Affected: 48
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.
Distribution
Worldwide - US Nationwide distribution in the states of DE, PA and the country of DE.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-09
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 162 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Shimadzu Corp. Analytical & Measuring Instruments Div. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Shimadzu Corp. Analytical & Measuring Instruments Div.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Shimadzu Corp. Analytical & Measuring Instruments Div. have FDA actions?
Shimadzu Corp. Analytical & Measuring Instruments Div. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0554-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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