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SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku Recalls

All product recalls associated with SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 57 recalls

Ceiling Type X-Ray Tube Support (Shimadzu) – Mounting Shaft Risk (2025)

Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.

High

FDAOct 16, 2025Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Fuse ULTRA Foot Plating System (CPM Medical) – Sterilization Update (2025)

Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States.

Moderate

FDASep 17, 2025Nationwide• CPM Medical Consultants, LLC.

Neo-Tee T-Piece Resuscitator (Mercury Medical) – Flow Controller Defect (2024)

Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.

12 3

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Moderate

FDADec 10, 2024Nationwide• Mercury Enterprises, Inc. dba Mercury Medical

FLUOROspeed (Shimadzu) – Image Display Issue (2024)

X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.

Moderate

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

SONIALVISION G4 (Shimadzu) – Image Display Problem (2024)

Moderate

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Trinias Unity (Shimadzu) – Movement Interference Risk (2024)

If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.

Moderate

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Neo-Tee Resuscitator (Mercury) – Manufacturing Step Issue (2024)

Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

High

FDAAug 30, 2024FL, IN, MI +2 more• Mercury Enterprises, Inc. dba Mercury Medical

BinaxNOW Strep A Test (Cypress) – Licensing Shipment Error (2024)

Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.

Low

FDAAug 20, 2024Nationwide• Cypress Medical Products LLC

Acceava Strep A Test (Cypress) – Licensing Shipment Error (2024)

Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.

Low

FDAAug 20, 2024Nationwide• Cypress Medical Products LLC

LVP Primary Administration Set (Cypress Medical) – Medication Flow Risk (2024)

The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.

Moderate

FDAAug 6, 2024Nationwide• Cypress Medical Products LLC

McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 10... (Cypress Medical Products LLC) – affected syringes lack fda clearance (2024)

Affected syringes lack FDA clearance.

High

FDAJul 24, 2024Nationwide• Cypress Medical Products LLC

FRT250 Cartridge (Pega Medical) – Incorrect Component (2024)

During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.

Low

FDAJul 4, 2024Nationwide• ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL 1111 Chomedey (A-13) E Laval Canada

Trinias Angiography System (Shimadzu) – Flat Panel Malfunction (2024)

Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.

Moderate

FDAJan 29, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Over-Head Ceiling Tube Support (Shimadzu) - Bolt Fastening Issue (2023)

Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to eliminate the risk of the device falling.

High

FDAApr 10, 2023Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

InPen Diabetes Management App (Companion Medical) – App Crash Risk (2022)

Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message may be displayed indicating the app has stopped or isn't responding. After the crash, a present dose reminder is not displayed, which may lead to delayed insulin therapy and potentially resulting in hyperglycemia.

High

FDANov 8, 2022Nationwide• Companion Medical, Inc.

McKesson Lap Sponge (Cypress Medical Products) – sterilization indicator issue (2021)

Manufacturer issued a recall due to an EO indicator color. The indicator should change from red to blue signifying sterilization. However, on one case of product, the indicators did not change

FDAAug 11, 2021VA• Cypress Medical Products LLC