FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: 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***"
- Recall number
- Z-0941-2012
- Recalling firm
- Toshiba American Medical Systems 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***"
- Status
- Terminated
- Initiated
- 2011-12-29
- Posted
- 2012-02-02
- Terminated
- 2014-03-24
- Reason
- It has been found that some of the starter cables used for x-ray tube high speed rotation are not sufficiently durable.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K083503"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28