Torrance, CA, United States
Shimadzu Medical Systems recalls
7 recalls recorded since 2018, most recently on 20 April 2026. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)5
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 April 2026
- Reason
- Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, The Bahamas, China, Denmark, H
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2294-2026
- Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Radiography System RADs
Ongoing Class II Medical devices
- Recall started
- 10 January 2022
- Reason
- It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
- Distribution
- U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, and WV. O.U.S.: N/A
- Initiated
- FDA Mandated
- Recall numbers
- Z-0869-2022, Z-0868-2022, Z-0867-2022
- MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
- MODEL: X-RAY TV SYSTEM SONIALVISION G4
- MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
Ongoing Class II Medical devices
- Recall started
- 16 December 2021
- Reason
- Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
- Distribution
- U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.
- Initiated
- FDA Mandated
- Recall numbers
- Z-0654-2022, Z-0655-2022
- Digital Angiography System Bransist safire Generator Model D150GC-40
- Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
Ongoing Class II Medical devices
- Recall started
- 18 November 2020
- Reason
- The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
- Distribution
- US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0556-2021, Z-0554-2021, Z-0555-2021
- MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-
- Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiog
- Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiogra
Ongoing Class II Medical devices
- Recall started
- 9 November 2020
- Reason
- There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.
- Distribution
- US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, ND, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0534-2021
- Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in t
Completed Class II Medical devices
- Recall started
- 4 November 2019
- Reason
- The DAP meters were found to be outside of tolerance.
- Distribution
- US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2591-2020
- Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radi
Terminated Class II Medical devices
- Recall started
- 12 January 2018
- Terminated
- 24 February 2022
- Reason
- When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.
- Distribution
- US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2060-2018
- Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the phy
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.