Z-0869-2022Class II

MODEL: X-RAY TV SYSSTEM SONIALVISION safire17

Name: Z-0869-2022 MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Creator: Shimadzu Medical Systems
Published: 2022-01-10
License: https://open.fda.gov/license/

Shimadzu Medical Systems / initiated 2022-01-10 / Open, Classified / root cause: software

FDA source

Shimadzu Medical Systems began a recall of MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 on 2022-01-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0869-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-10
Posted: 2022-04-07
Recalling firm: Shimadzu Medical Systems
Product: MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: On or about 1/7/2022, the firm sent an "Urgent: Voluntary Medical Device Recall Notice" to customers informing them that there is a potential issue with the adjustment procedure of the generator on the SonialVision (G$ and safire) Systems and FluoroSpeed X1 Systems. As a result of the Recalling Firm's investigation and testing it was proven that there is a problem with the adjustment procedure documented for the calibration of the system xray generator. This problem occurs during the calibration of the fluoroscopic mode which could cause x-ray radiation dose rate to exceed regulation and/or standards. As a result of the investigation, it was determined that the calibration procedure for the generator to instruct the installer requires updating. This problem if not corrected could cause improper calibration which would lead to dose levels above regulations. Therefore, the Recalling Firm will release notification to update calibration instructions and to conduct calibration of the system following revised calibration procedure. Customers are instructed to: -Check their systems for the affected generators/systems. -Contact their distributor to schedule a system update and calibration. -Pay attention to the following points until the calibration/update is completed: If the SID (distance between the X-ray focus and the FPD input surface) is 1200 mm or more, it has been confirmed that the dose rate does not exceed the specified value. If SID 1200 mm cannot be used and SID 1100 mm is used, the following points must be kept in mind until readjustment. When fluoroscopy is performed under the condition where the fluoroscopy tube voltage is maximum, the dose rate may increase by up to 8 percent from the adjustment value at the time of installation and exceed the dose regulation and/or standard value. Therefore, pay attention to the fluoroscopy cumulative time so as not to perform fluoroscopy for a long time under the condition where the fluoroscopy tube voltage is
Quantity in commerce: 12 systems
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
Product codes and lots: Model: SonialVision safire: Generator Number: D150-40 Serial Numbers: 3M5249D41006 3M5249D2A004 3M5249D34001 3M5249D37006 3M5249D32012 3M5249D35002 3M5249D1C013 3M5249D31009 3M5249D29002 3M5249D33003 3M5249D2C004 3M5249D22013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0869-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0867-2022	Class II	Ongoing	FDA Mandated	2022-04-13	2022-04-06
Z-0868-2022	Class II	Ongoing	FDA Mandated	2022-04-13	2022-04-06
Z-0869-2022	Class II	Ongoing	FDA Mandated	2022-04-13	2022-04-06

Product code JAA

K190373Class IISonialVision G4Shimadzu Corporation / cleared 2019-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)