Shimadzu Autosampler Devices Subject to Water Damage Affecting Main Board
Water condensation may accumulate under the autosampler's thermal insulation and damage the main board, causing communication errors and delays in laboratory testing. Two Shimadzu models are affected: SIL-40C XR CL and SIL-40C X3 CL.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II device recall with no reported hospitalizations or patient injuries. The hazard is equipment failure resulting in operational delays to laboratory testing, not direct patient harm.
Plain-English summary
Shimadzu is recalling certain autosampler units used in laboratory analysis, specifically models SIL-40C XR CL and SIL-40C X3 CL. A total of 48 devices have been distributed in the United States, with distribution confirmed in Delaware and Pennsylvania.
The devices may experience main board failures due to condensation water accumulating in the gap between the thermal insulation material and the base of the unit. When water drips onto the main board, it can cause communication errors between circuit boards, HOME POSITION errors, or SLIP errors in the XYZ drive units, depending on where the water makes contact.
These failures could result in delays to patient sample testing. Laboratories operating affected units should contact Shimadzu for guidance on remedial actions, verifying their equipment serial numbers against the FDA recall documentation.
The recalled product
- Product
- Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
- Manufacturer
- Shimadzu Corp. Analytical & Measuring Instruments Div.
- Category
- Medical Device
- Hazard
- water-damage
- equipment-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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