PlainRecalls

Shimadzu Medical Systems

18 recalls on record · Latest: Apr 13, 2022

Shimadzu Medical Systems Recall Insight

Shimadzu Medical Systems appears on 18 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.021% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Apr 13, 2022, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 18 entries, severity tagging shows 0 critical, 18 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 18 of 18 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (18). The date window on this page runs from Nov 14, 2012 to Apr 13, 2022.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Apr 13, 2022

MODEL: X-RAY TV SYSSTEM SONIALVISION safire17

FDA Devices Moderate Apr 13, 2022

MODEL: X-RAY TV SYSTEM SONIALVISION G4

FDA Devices Moderate Mar 9, 2022

Digital Angiography System Bransist safire Generator Model D150GC-40

FDA Devices Moderate Dec 16, 2020

MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdomi…

FDA Devices Moderate Dec 16, 2020

Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intende…

FDA Devices Moderate Dec 16, 2020

Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic ima…

FDA Devices Moderate Jul 22, 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 inte…

FDA Devices Moderate Jun 20, 2018

Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the h…

FDA Devices Moderate Jan 4, 2017

Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high…

FDA Devices Moderate Dec 30, 2015

Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital rad…

FDA Devices Moderate Nov 18, 2015

Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.

FDA Devices Moderate May 14, 2014

Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray de…

FDA Devices Moderate Jun 12, 2013

Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospita…

FDA Devices Moderate Nov 14, 2012

0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-…

FDA Devices Moderate Nov 14, 2012

0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system…

FDA Devices Moderate Nov 14, 2012

0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who…

FDA Devices Moderate Nov 14, 2012

R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-8…

FDA Devices Moderate Nov 14, 2012

0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cann…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds