Toshiba Infinix-i X-Ray System
Medical device recall Z-0994-2013. Published in FDA’s Enforcement Report on Apr 3, 2013.
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 3, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 95 units 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?
Lost and incorrect images. When using the “F-Rec” fluoroscopy image acquisition recording option in the “manual mode” an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
95 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
NO. SERIAL NO. LASTFOUR MANUFACTURE DATE 1 A3SS2014 2014 MAY 2003 2 UVBlOS2001 2001 MAY 2010 3 USC1062001 2001 JUNE 2010 4 U4A09X2002 2002 OctOBER 2009 5 U4A09Y2003 2003 NOVEMBER 2009 6 U4A10X2006 2006 OctOBER 2010 7 UEA1072003 2003 JULY…
Every code shown here, 1,996 characters
NO. SERIAL NO. LASTFOUR MANUFACTURE DATE 1 A3SS2014 2014 MAY 2003 2 UVBlOS2001 2001 MAY 2010 3 USC1062001 2001 JUNE 2010 4 U4A09X2002 2002 OctOBER 2009 5 U4A09Y2003 2003 NOVEMBER 2009 6 U4A10X2006 2006 OctOBER 2010 7 UEA1072003 2003 JULY 2010 8 UDA09X2002 X2002 SEPTEMBER 2009 9 UCA1092005 2005 SEPTEMBER 2010 10 U4B0992006 2006 SEPTEMBER 2009 11 U4A1012004 2004 JANUARY 2010 12 UCA10S2006 2006 MAY 2010 13 UEA09Y2002 2002 NOVEMBER 2009 14 W2A1012082 2082 JANUARY 2010 15 W1C0652303 2303 MAY 2006 16 UDA0952001 2001 MAY 2009 17 UDA0952002 2002 MAY 2009 18 UUA1042011 2011 APRil 2010 19 UCA1022003 2003 FEBRUARY 2010 20 UKA1022007 2007 FEBRUARY 2010 21 U4B1062007 2007 JUNE 2010 22 A3592048 2048 SEPTEMBER 2003 23 UDA09Z2005 2005 DECEMBER 2009 24 UUA09Y2004 2004 NOVEMBER 2009 25 UUA09Y2005 2005 NOVEMBER 2009 26 U6A0992002 2002 SEPTEMBER 2009 27 W1D07Z2456 2456 DECEMBER 2007 28 U4A1042005 2005 APRil 2010 29 UUA1052012 2012 MAY 2010 ¿30 U7BlOS2001 2001 MAY 2010 31 UKA09Z2005 2005 DECEMBER 2009 32 A3S32005 2005 MARCH 2003 33 UCA1062007 2007 JUNE 2010 34 UTA1092003 2003 SEPTEMBER 2010 35 UCA09Z2002 2002 DECEMBER 2009 36 U6A1072009 2009 JULY 2010 37 U4B0982005 2005 AUGUST 2009 38 U4B0972004 2004 JULY2009 39 W1D0752394 2394 MAY 2007 40 UFB1042002 2002 APRil 2010 41 UDB1072007 2007 JULY 2010 42 UCA0972001 2001 JULY 2009 43 UCA0972001 2001 JULY 2009 44 W1D0722373 2373 FEBRUARY 2007 45 U6A1062008 2008 JUNE 2010 46 U6A103200S 2005 MARCH 2010 47 UCA1072004 2004 JULY 1010 48 UTA1062002 2002 JUNE 2010 49 W1D0732380 2380 MARCH 2007 50 A3622065 2065 FEBRUARY 2003 51 A3622066 2066 FEBRUARY 2003 52 UDA0962001 2001 JUNE 2009 53 UUA0982001 2001 AUGUST 2009 54 UKA1042008 2008 APRil 2010 ¿55 UKA1082011 2011 AUGUST 20010 56 U4A08Y2001 2001 NOVEMBER 2008 57 U4A0922002 2002 FEBRUARY 2009 58 U6A0972001 2001 JULY 2009 59 U6A1012003 2003 JANUARY 2010 60 UCA1022004 2004 FEBRUARY 2010 61 UKA09Y2004 2004 NOVEMBER 2009 62 U4B0962003 2003 JUNE 2009 63 U6AlOS2007 2007 MAY 2010 64 UKA09Z2006 2006 DECEMBER…
FDA’s list runs to 2,960 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.
USA nationwide. No international.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Nov 8, 2012.
- FDA classified it on Mar 25, 2013.
- FDA’s Enforcement Report published it on Apr 3, 2013.
- FDA terminated it on Mar 26, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Toshiba American Medical Systems Inc, of Tustin, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- 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 2,960 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.