MODEL: X-RAY TV SYSTEM SONIALVISION G4
Medical device recall Z-0868-2022. Published in FDA’s Enforcement Report on Apr 13, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 13, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 37 states named in where it went
- 176 systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is 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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MODEL: X-RAY TV SYSTEM SONIALVISION G4
176 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model: SonialVision G4 Generator Number: D150-40 Serial Numbers: 41C35166C003 41C3536B4001 41C351683006 41C3516B3001 41C35169C002 41C351699002 41C351699001 41C3517AA001 41C35169B002 41C351671001 41C3516A3001 41C351661002 41C351671007…
Every code shown here, 1,989 characters
Model: SonialVision G4 Generator Number: D150-40 Serial Numbers: 41C35166C003 41C3536B4001 41C351683006 41C3516B3001 41C35169C002 41C351699002 41C351699001 41C3517AA001 41C35169B002 41C351671001 41C3516A3001 41C351661002 41C351671007 41C351683003 41C351671005 41C35179B004 41C351674001 41C35168B002 41C3517AA002 41C351685004 41C35165B002 41C3535A5001 41C353597001 41C35359C001 41C351674004 41C351685003 41C35164C001 41C351641001 41C351671004 41C351679001 41C3535A1001 41C3535A3001 41C351664004 41C351679006 41C351684004 41C351674002 41C3535A2002 41C351669002 41C351646002 41C35164A001 41C35359C002 41C351692001 41C35168B001 41C351653004 41C351664002 41C351673004 41C351663002 41C35164B001 41C351683001 41C351683002 41C351799001 41C351686002 41C351646001 41C351679005 41C351693003 41C351665002 41C35179A001 41C35165A003 41C35168A003 41C35179B005 41C35179B003 41C351671006 41C351689001 41C351799002 41C351641002 41C351671002 41C351676002 41C35165A001 41C351643001 41C35165A002 41C351655001 41C351695003 41C351647001 41C35166A002 41C351693002 41C351695001 41C351664005 41C351673003 41C35166C001 41C3535AC001 41C35166A001 41C35168B003 41C35169C001 41C3517B1001 41C3518B4002 41C351653002 41C3518B4001 41C35168A004 41C351665003 41C351678002 41C351684001 41C351683005 41C351693001 41C351671003 41C35179C001 41C351677001 41C35167A001 41C35165B001 41C351676001 41C351662001 41C35168C002 41C351668002 41C351679004 41C351677002 41C35179B001 41C351684005 41C351692003 41C351653003 41C351666002 41C351682002 41C351685001 41C351677003 41C353597002 41C3517A2002 41C351661001 41C35168C005 41C35168A002 41C35169A001 41C351663001 41C351692004 41C35168C004 41C351664001 41C351681001 41C351651002 41C351684006 41C3535A2001 41C351679007 41C351799003 41C351667001 41C351678001 41C351683004 41C351681002 41C351656001 41C351655003 41C3516B3002 41C3517B3002 41C3518B5001 41C3518B5002 41C3518B7001 41C3536B7001 41C351656002 41C35166C002 41C35168C001 41C351679002 41C351651001 41C351686001 41C351692002 41C3517A2001…
FDA’s list runs to 2,352 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
37 states and territories.
Every one of them
- Alaska
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Washington
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 10, 2022.
- FDA classified it on Apr 6, 2022.
- FDA’s Enforcement Report published it on Apr 13, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Shimadzu Medical Systems, of Torrance, CA.
- Who began it, in FDA’s words: FDA Mandated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,352 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.