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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Category
- Medical Device
- Affected units
- 48
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
Related recalls
Same manufacturer · Shimadzu Corp. Analytical & Measuring Instruments Div.
See all →- HighShimadzu Autosampler Water Intrusion May Cause Electrical Short Circuit
FDA (Devices) · 2024-12-04
Same hazard · water damage
See all →- High
- HighMedline sterile surgical procedure packs recalled due to water damage
FDA (Devices) · 2023-06-07
- High
- HighCARTO VIZIGO Guiding Sheath Recalled Due to Water-Damaged Sterile Packaging
FDA (Devices) · 2022-09-14
- Severe
Similar recalls
- HighShimadzu Autosampler Water Intrusion May Cause Electrical Short Circuit
FDA (Devices) · 2024-12-04
- HighInpeco FlexLab Augomation System Recalled for Potential Sample Dilution
FDA (Devices) · 2020-06-10
- HighShimadzu Ceiling X-ray Tube Support Recalled for Potential Cracks
FDA (Devices) · 2017-07-05
- ModerateInpeco Accelerator a3600 Automation System Recalled for Sample Dilution Risk
FDA (Devices) · 2020-06-10
- HighShimadzu X-ray High Voltage Generator Recalled for Oil Leak Risk
FDA (Devices) · 2017-01-04
- HighX-Ray Ceiling Tube Support System Recalled Due to Loose Fixing Bolts
FDA (Devices) · 2023-08-09