Z-0941-2012

DRAD-3000E: Radrex-i X-ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL...

Name: Z-0941-2012 DRAD-3000E: Radrex-i X-ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL...
Creator: Toshiba American Medical Systems Inc
Published: 2011-12-29
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2011-12-29 / Terminated / root cause: manufacturing process

FDA source

Toshiba American Medical Systems Inc began a recall of DRAD-3000E: Radrex-i X-ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL RADIOGRAPHY SYSTEM RADREX-i DRAD-3000E Systems Data No... on 2011-12-29. The reason FDA records is "It has been found that some of the starter cables used for x-ray tube high speed rotation are not sufficiently durable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0941-2012
Status: Terminated
Initiated: 2011-12-29
Posted: 2012-02-02
Terminated: 2014-03-24
Recalling firm: Canon Medical Systems USA, Inc.
Product: DRAD-3000E: Radrex-i X-ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL RADIOGRAPHY SYSTEM RADREX-i DRAD-3000E Systems Data No. MSDXR0144EA***"
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: It has been found that some of the starter cables used for x-ray tube high speed rotation are not sufficiently durable.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recall notification titled "URGENT: MEDICAL DEVICE CORRECTION", was sent on 12/29/11 to customers via certified mail. The letter informed the customer of an issue with the starter cable used for high speed rotation on the Radrex X-Ray System. The letter also informs customers of the corrective measures: a replacement cable will be installed on your system to prevent this issue from occurring. An 800 number was provided for any questions regarding the letter.
Quantity in commerce: 39
Distribution: Class II Recall - Nationwide Distribution (USA) - Including the states of VA, IL, CA, PA, TN, OH, LA, TX, OK, AR, AZ, MS, WV, TN, WI, NJ, MN, NY, IA, FL, and Washington D.C.
Product codes and lots: Lot number is not utilized. Serial numbers of the following: U2A0892009, U2A08X2010, U2A08X2011, U2A08Y2012, U2A08Z2013, U2A08Z2014, U2A0912015, U2A0912016, U2A0922017, U2A0942019, U2A0942020, U2A0942021, U2A0952022, U2A0952023, U2A0972024, U2A0972025, U2A0982026, U2B09X2027, U2B09Y2028, U2B09Y2029, U2B09Z2030, U2B1042031, U2B1042032, U2C1052033, U2C1062034, U4A0982001, U4A0982002, U4A0992003, U4A09X2004, U4A09Z2005, U4A09Z2006, U4A09Z2007, U4A1022009, U4B1022010, U4B1032011, U4B1052012, U4B1052013, U4B1062014, U6A0972001 and U4B1012008.

Product code MQB

K083503Class IIDrad30003/radrex-IToshiba America Medical Systems, In.C / cleared 2009-02-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)