Device recall: MODEL: X-RAY R/F SYSTEM FLUOROspeed X1

Class II FDA enforcement event 89596. Recall start date: 10 Jan 2022. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

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

Shimadzu Medical Systems started this device recall on 10 Jan 2022. The firm address in the FDA record is in Torrance, CA. FDA put the recall in Class II. FDA event 89596 has 3 product records. The first FDA enforcement report date is 13 Apr 2022. The record gives the status Ongoing.

FDA enforcement report The 3 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

Shimadzu Medical Systems, Torrance, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: FDA Mandated.

Products

3 product records in the event.

FDA event 89596: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0867-2022	MODEL: X-RAY R/F SYSTEM FLUOROspeed X1	25 systems	Class II	Ongoing	13 Apr 2022
Z-0868-2022	MODEL: X-RAY TV SYSTEM SONIALVISION G4	176 systems	Class II	Ongoing	13 Apr 2022
Z-0869-2022	MODEL: X-RAY TV SYSSTEM SONIALVISION safire17	12 systems	Class II	Ongoing	13 Apr 2022

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2022: 839
Share of these events in Class II: 88%
Product records in this event: 3Median of the firm: 1
Events of the firm on the register: 16

Other events of the firm

Other FDA enforcement events of Shimadzu Medical Systems
Initiated	Product (first record)	Type	Class	Records
20 Apr 2026	Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-	Device	Class II	1
16 Dec 2021	Digital Angiography System Bransist safire Generator Model D150GC-40	Device	Class II	2
18 Nov 2020	Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designe	Device	Class II	3
9 Nov 2020	Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product	Device	Class II	1
4 Nov 2019	Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is	Device	Class II	1
12 Jan 2018	Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for	Device	Class II	1
20 Nov 2016	Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray	Device	Class II	1
20 Nov 2016	Shimadzu X-ray TV System, Catalog No. SONIALVISION G4	Device	Class II	1
31 Mar 2016	X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, a	Device	Class II	1
10 Nov 2015	Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to	Device	Class II	1

Shimadzu Medical Systems: all 16 events

Official channels

FDA enforcement report Z-0867-2022The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 89596. https://recallregister.com/fda/ii/89596/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this 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
What quantity of product is in FDA event 89596?: The event has 3 product records. The first record gives this quantity: 25 systems
How did the recall start?: The FDA record says: FDA Mandated
How many device recalls of 2022 have the same class?: 88% of the 839 device events that started in 2022 are in Class II.