FDA Device recall Z-0994-2013
Toshiba Infinix-i X-Ray System
- FDA Device
- Class II
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class II recall of Toshiba Infinix-i X-Ray System by Toshiba American Medical Systems, citing 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 st….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0994-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-08 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | US |
Product
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
Reason
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.
Identifiers
| code_info | NO. SERIAL NO. LASTFOUR MANUFACTURE DATE 1 A3SS2014 2014 MAY 2003 2 UVBlOS2001 2001 MAY 2010 3 US…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 U6A09 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0994-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.