Toshiba American Medical Systems Inc Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system
Brand
Toshiba American Medical Systems Inc
Lot Codes / Batch Numbers
Serial Numbers: U2A0872007, U2A08Y2012, U2A08Z2014, U2A0892009, U2A08Z2013, U2A0912016, U2A08X2010, U2A08X2011, U2A0862006, U2A0832002, U2B0852005, U2A0832001, U2B0842003, U2A0942019, U2A0942020, U2A0942021, U2A0942017, and U2A0882008.
Products Sold
Serial Numbers: U2A0872007, U2A08Y2012, U2A08Z2014, U2A0892009, U2A08Z2013, U2A0912016, U2A08X2010, U2A08X2011, U2A0862006, U2A0832002, U2B0852005, U2A0832001, U2B0842003, U2A0942019, U2A0942020, U2A0942021, U2A0942017, and U2A0882008.
Toshiba American Medical Systems Inc is recalling Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrost due to 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 s. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026