FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system
- Recall number
- Z-1177-2010
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system
- Status
- Terminated
- Initiated
- 2009-05-22
- Posted
- 2010-03-22
- Terminated
- 2012-03-21
- Reason
- Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system due to a software bug that results in a loss of image.
- Root cause
- Component design/selection
- Action
- An Urgent - Medical Device Correction letter was sent to customers. The letter described the issue, the corrective action, and the avoidance. Toshiba America Medical Systems informed customers that software was being prepared to address the issue and planned to send representatives to each customer affected by the field correction to provide a software upgrade to the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system. Customers were to complete the attached customer reply form. Questions were to be directed to Aaron Ybarra, X-ray Product Manager at 800-421-1968, ext. 2492.
- Quantity
- 20
- Distribution
- Nationwide Distribution -- Including states of PA, VA, OH, TN, LA, IL, CA, MT, AZ, and TX.
- Lot, serial or model codes
- Serial Numbers: U2A0872007, U2A08Y2012, U2A08Z2014, U2A0892009, U2A08Z2013, U2A0912016, U2A08X2010, U2A08X2011, U2A0862006, U2A0832002, U2B0852005, U2A0832001, U2B0842003, U2A0942019, U2A0942020, U2A0942021, U2A0942017, and U2A0882008.
- 510(k) numbers
- ["K073165"]
- 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